Links to 843 Entry-Level Biotechnology & Life Science Jobs

We are seeking a highly motivated and detail-oriented Research Associate to join our dynamic Next-Generation Sequencing (NGS) product development team. In this hands-on role, you will support the evaluation, optimization, and advancement of cutting-edge NGS solutions. You will perform high-quality laboratory experiments, contribute to critical data generation, and help drive successful internal and external adoption of our products. This position is ideal for someone passionate about molecular biology and eager to grow their expertise in NGS workflows, product development, and applications.

You're passionate about science and want to be in a hands-on role supporting our transgene analysis team. The Research Associate I will assist with basic Molecular Biology techniques and will focus on generating protein expression data from cell and tissue samples.

As an Integration and Test Engineer, you will have a broad role scope owning vehicle systems, integration, and test. Ultimately, engineers are responsible for the vehicle and ensuring all systems are ready for launch and operations. To accomplish this, engineers need knowledge of system design, manufacturing, test, and operations. This role interfaces with all engineering departments and Integration and Test Engineers must be able to drive conflicting requirements to implemented solutions.

Vaxcyte is looking for an energetic and talented Associate Engineer II to contribute to the Polysaccharide Upstream Pilot Plant as this person will be responsible supporting design and execution of experiments at pilot scale of polysaccharide production and scale down model experiments of process operations, contributing towards the process characterization of the polysaccharide process. The successful candidate will have knowledge and practical laboratory upstream process experience in executing, supporting, or developing processes such as fermentation, clarification processes (centrifugation experience is a plus), and tangential flow filtration. In addition, the candidate must have experience in performing plate-based colorimetric assays (Bradford and Lowry assays are a plus).

We are seeking a motivated and detail-oriented Research Associate with strong hands-on experience in chromatographic analysis to support QC release and stability testing. The successful candidate will perform routine cGMP QC testing using HPLC methods (RP-HPLC, SEC, IEX), Agilent HPLC systems, and additional supporting assays in a fast-paced, collaborative environment. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

The Scientist role within the Chemical Development group will focus on the synthesis, process development, and analytical strategy for protected phosphoramidite precursors used in therapeutic oligonucleotide API manufacturing. This position is key to building Veranova’s commercial capability in producing high-quality oligonucleotide building blocks. The ideal candidate will have strong expertise in phosphoramidite chemistry, including impurity profiling and customer-specific requirements. This role will also collaborate closely with the Analytical Team to establish robust characterization and control strategies that ensure exceptional product quality.

Review in-process batch records finished product batch records (Pharm, and/or MPD), and intermediate analytical records. Release intermediate materials. Assess the manufacturing operations and process documentation for compliance to GMP’s and Standard Operating Procedures. Participates in the evaluation and triage of events, deviations, and unplanned activities that impact processes and/or materials. Assure deviations are appropriately reported. Identifies improvement opportunities and participates on project teams geared toward continuous improvements for the various elements of the quality system. Perform annual retain inspections. Assists with the revision of SOP’s, QF’s and training modules as needed. Attends training classes and seminars as needed.

The Clinical Trial Assistant (CTA) will provide administrative support to the Clinical Operations Team in full spectrum of clinical trial activities related to study start up, study maintenance, study closure and vendor management in compliance with Good Clinical Practice (GCP), Standard Operation Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

The QC Labeling Inspector is responsible for maintaining a high level of inventory accuracy and integrity within the Tissue Bank. Performs final product labeling and inspections, manages transport and storage of quarantine tissue, and maintains labeling supplies. Promotes Lean Behaviors across the organization (This includes Participating in Try storming, Brainstorming and Lean Related Initiatives). Promotes Usage of Problem Solving. Ensure that Labeling Operations are in Compliance with the State and Federal Regulations and AATB Standards.

Vyriad is a clinical stage biotechnology company based in Rochester MN. We are developing the next generation of targeted genetic medicines for cancer therapy. The Bioproduction Technologist will be responsible for upstream and/or downstream process development and GMP manufacturing of oncolytic viruses, lentiviral vectors and other biologics for clinical trials. The Bioproduction Technologist plays a vital role in the day-to-day process development projects and manufacturing operations in compliance with cGMP standards. Virus and gene therapy manufacturing operations involve aseptic processing in a pharmaceutical cleanroom facility, large-scale cell culture in shake flasks and bioreactors, vector generation, purification, concentration, and fill and finish operations, according to established standard operating procedures (SOPs). In addition, staff are responsible for the daily operations and environmental monitoring of the GMP facility to ensure compliance with applicable regulations.

The Scientist I, Analytical Development position is responsible for the development and implementation of analytical characterization methods for a range of pharmaceutical dosage forms to support formulation, process, and specification development. This position collaborates with product development scientists in developing therapeutic drug products utilizing the company's proprietary XeriSol® and XeriJect® platform technologies. This position also supports Quality Control and CMC functions in establishing product specifications, stability programs, material qualification, method validation, method transfer, and process validation.

Yokogawa is seeking an Analytical Systems Engineer with responsibility for delivering customer satisfaction through the application of specialized chemical engineering knowledge and professional judgment in the analysis, design, and implementation of analytical systems. This includes the use of advanced engineering tools and methodologies such as gas chromatographs, continuous emission monitoring systems (CEMS), process gas analyzers, and sample conditioning systems. The role requires autonomous execution of complex engineering tasks, including the development and optimization of analytical strategies, integration with control systems, and compliance with environmental and safety regulations. The Analytical Systems Engineer acts as a Subject Matter Expert (SME) in chemical process analysis, often leading technical decisions and providing engineering solutions that align with industry standards and client requirements.

The Specialist Mfg Tech works out of our Abbott Park (Lake Bluff), IL location in the Core Diagnostics Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to the Code of Federal Regulations, ICH GCP, and ISO14155. This position is onsite in our Alameda, CA location.

Perform production line duties required to meet production goals while complying with quality standards and safety requirements. Operate production equipment and complete documentation in accordance with cGMP’s and department SOP’s while monitoring product to ensure quality standards are maintained.

Perform production line duties required to meet production goals while complying with quality standards and safety requirements. Operate production equipment and complete documentation in accordance with cGMP’s and department SOP’s while monitoring product to ensure quality standards are maintained.

We are seeking a Lab Technologist to grow with the company, contributing to our company goals and meeting customer needs. The Lab Technologist will perform hands-on commercial sample assays, support production activities by developing QC protocols and maintain/establish Standard Operation Procedures (SOPs) with compliance with ISO 9001 and 17025 standards.

This position is responsible to ensure all center activities are performed in accordance with standard operating procedures (SOPs) and the center is ready for inspection by regulatory agencies at any time. The Quality Assurance Specialist (QAS) assists in the development of policies, procedures, and processes to ensure the necessary requirements and controls are appropriately addressed in an effort to reduce or eliminate the potential of errors. This may be identified through scheduled audits, performance observations, or record review. This position assists in the gathering and compilation of data and information to provide appropriate monitoring of all quality initiatives and programs. The QAS is responsible for ensuring an appropriate investigation of any deviations from process or procedure is complete. The investigation may require root cause analysis and effective corrective or preventative actions. Monitoring for the recurrence or the potential for recurrence is a critical component of data analysis.

Aether is looking for a hands-on Research Associate to join our Materials Development team. You will play a central role in how our materials are printed, tested, and understood - operating our fleet of 3D printers, running mechanical and thermal characterization, and generating high-quality data that drives product development and customer success. This is a junior, execution-focused role with significant room for growth. You’ll start as a generalist across printing and testing workflows, and over time develop a deep intuition for 3D printing behavior and materials performance. As our R&D capabilities expand beyond FFF and FDM, you will have opportunities to help build novel testing workflows and support application development.

Responsible for supporting customers through on-site activities such as installation, implementation, maintenance and repair of company and multi-vendor systems solutions which may include hardware, software and networking products as well as operating systems. Installs and optimizes hardware/software/network products and configurations at customer sites. Diagnoses and resolves product performance problems. Performs maintenance and repair services. Ensures customer satisfaction by advising customers on preventive maintenance and configurations, which may impact product performance. Proactively responds to potential equipment or software issues to prevent unplanned interruption of customers' business. Delivers (does not design) fully integrated solutions, which may include peripherals, communications, operating systems and applications software. Serves as an internal resource on technical issues and manages product escalations Collaborates with Agilent teams such as Support, Sales, Marketing and R&D to provide solutions to customers. May have knowledge of third-party products. May deliver internal technical training and maintenance seminars and workshops for field engineers or customers. May train other field engineers or customers. May calibrate equipment on-site for large volume customers. May qualify leads. Must consent to participate and meet Agilent approved customer/vendor credentialing requirements necessary to gain access to customer sites. Requirements may include, but are not limited to, proof of identification, proof of certification to perform the work required, customer health and safety requirements, etc.

The Quality Support position is responsible for assisting in operation related quality documentation and tasks including but not limited to open/write up NCMRs and/or ABNs with known root cause and has standard way of revolving. This position will also be responsible for reworking activities that are approved by SHL customers but are not part of daily operation of molding and/or assembly.

Responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions to ensure adequate systems and inspection methods and tools are used throughout the plants for molding or assembling products. Understanding customer requirements and implementing required documentation, action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer’s products meet specifications at all phases within our process.

The Associate Microbiologist will conduct microbiological analysis of cannabis flower, concentrates and infused products as required by state cannabis regulatory body regulations within an ISO 17025 accredited laboratory. The Associate Microbiologist will be responsible for coordinating scheduling with the Laboratory Manager and conducting sample analysis. As time allows, the Associate Microbiologist will also be cross-trained to conduct sample onboarding, preparation, and extraction for subsequent chemical analyses.

We are seeking a highly motivated and experienced Research Associate/Associate Scientist to join our growing Assay Development team, with hands-on experience running ultrasensitive immunoassays and the desire to be at the forefront of innovative research. This individual will play a pivotal role in advancing Spear Bio’s new range of ultrasensitive immunoassays and assay biomarker programs.

The Regulatory Affairs (RA) Specialist is responsible for supporting global regulatory submissions and compliance activities to ensure medical device products meet applicable regulatory requirements throughout their lifecycle. This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.

The Quality Analyst in our Brooklyn Park, Minnesota location is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. In this role the Quality Analyst will lead complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. You will execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

The Quality Analyst in our Libertyville, IL location is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, and/or ISO 11137 and other applicable regulatory standards. In this role the Quality Analyst will lead complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. You will execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

Stratus Therapeutics is seeking a motivated Manufacturing Associate/Sr. Manufacturing Associate to support routine GMP Manufacturing operations. This includes day-to-day operational tasks including but not limited to Cell Culture in a clean room environment, GMP Materials Logistics, and Environmental Monitoring within Stratus GMP manufacturing space. This is an on-site role, primarily in Watertown, MA with occasional work in Cambridge MA. Some travel between sites is required.

Stryker is hiring a Quality Engineer to support our Neurovascular division in Salt Lake City, Utah. This is an onsite role requiring in-office presence 5 days per week. As Quality Engineer, you will champion quality and lean methodologies, drive process improvements, and ensure compliance to deliver superior products to patients and customers.

The Manufacturing Engineer contributes to medical device product design, development, manufacturing, and testing in accordance with the company’s Quality System. Helps generate design outputs where required through interface with cross-functional team members.

The Project Engineer is responsible for the strategic oversight and hands-on management of building systems, infrastructure projects, and utility operations across the organization. This role ensures optimal performance, safety, and compliance of all facilities-related functions, including HVAC, electrical, plumbing, and environmental systems. The Engineer will lead cross-functional initiatives, manage capital projects, and serve as a technical expert in building operations, cleanroom design, and sustainability efforts. The ideal candidate operates independently and proactively, driving continuous improvement and operational excellence.

The QA Associate I role is responsible for providing general support to the Quality department. This role helps to maintain the quality management system under close supervision and guidance. QA Associate I is responsible for carrying out general quality functions or activities, as assigned. The QA Associate I receives guidance on workload prioritization from the team lead or management but is ultimately responsible for organizing and executing their projects and daily standard workload in a manner which meets the schedules of the operational teams whom they support. The QA Associate I is an on-site role located in San Jose, CA.

Supports engineering activities such as design and execution of system level testing. Includes development of protocols, test methods, and test equipment required to verify system performance.

The TD2 Research Associate - In Vitro Pharmacology is involved in many aspects of laboratory operations primarily tissue culture activities, various cell-based assays, and molecular biology experiments. This position requires great attention to detail while working in a deadline-driven environment.

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

Terray Therapeutics is seeking a highly independent, motivated, and creative protein biochemist to join our preclinical team. An ideal candidate will have full responsibility of protein quality control workflows and be a pivotal member in collaboration between our screening and assay development teams. Successful candidates will be expected to be familiar with basic physical properties of targets of interest (based on literature and experimental sources) and play a key role in protein engineering, initial assay development and optimization. This position offers a unique opportunity to have an independent role and be a pivotal part of a multidisciplinary team in the frontiers of drug discovery.

As a Laboratory Supervisor you will play a crucial role in ensuring the smooth and efficient operation of our laboratory unit. This position involves supervising daily work activities, maintaining high standards of scientific and administrative operations, and ensuring compliance with all safety and quality protocols. Key responsibilities include operating, maintaining, and repairing clinical laboratory equipment, performing routine preventive maintenance, calibrations, and safety checks, and overseeing weekly and monthly Quality Control processes. Additionally, the supervisor will manage the Quality Control database and assist in setting up and validating new assays as directed by the manager.

A successful person will perform Environmental Monitoring tasks in support of Steriles production within classified areas. The individual is encouraged to follow the 4i Values that are held in high regards by the company when completing their work. The four values are integrity, innovation, intensity, and involvement. The job function includes aseptic technique which requires the individual to gain knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured. Typical shift hours are 6pm-6am on a 2-2-3 rotating schedule.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Carries out management of engineering projects including estimating costs, sourcing, identifying, specifying, purchasing and installing equipment, crafting/modifying existing or new facilities, and the commissioning and qualification of equipment, utilities and facilities to meet site/company requirements.

As a Senior Tech Ops Engineer, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives. The Sr Tech Ops Engineer provides strategic direction and technical expertise for site Commissioning and Qualification (C&Q) activities for equipment, utilities and facilities. To include execution of C&Q work for utilities, facilities and global applications as well as maintenance and execution of periodic performance qualification schedule and reviews. This role serves as a Center of Excellence, driving alignment with global and industry engineering standards. The engineer supports site critical programs related to C&Q while also supporting capital project execution and site-wide technical initiatives. The position plays a key role in shaping the site’s technology roadmap, ensuring operational excellence, and fostering a self-sustaining technical work structure for the Focus Factory Manufacturing Technology teams.

As an Associate Scientist in the CMI group, you will play a critical role in generating high-quality cellular immunology data in a regulated laboratory setting to support Pfizer’s vaccine programs. The primary focus of this role is high-throughput flow cytometry to analyze cellular immune responses in clinical and non-clinical samples. You may also support additional immunological assays such as ELISPOT and other biofunctional methods. This position involves routine testing, assay development, and data analysis, all performed in compliance with Good Laboratory Practices (GLP) and internal standards.

Conduct and support laboratory operations, including sample preparation, data collection, and analysis. Apply technical skills to assignments, ensuring high-quality results and solving moderately complex problems with sound judgment. Follow procedures with general instructions, maintaining compliance with regulatory standards and working under moderate supervision. Identify activities to support team goals, contributing to overall project success and ensuring adherence to project timelines. Perform testing on clinical and commercial products, raw materials, and validation samples, maintaining a neat and orderly work area. Independently write Standard Operating Procedures, technical reports, project plans, and other documents. Train junior colleagues, develop training plans, oversee training activities, and handle laboratory investigations for events and Out of Stock results. Create, review, and approve compliant test method transfer and validation protocols, reports, and equipment qualification/computer validation records.

We seek an enthusiastic and curious scientist interested in participating in all aspects of the hit-to-lead drug discovery process. The opening is at our new state-of-the-art facility in Canton, MA. The successful candidate will engage in the Immuno Oncology research areas of the company and will work with a successful team of international senior scientists located in the USA and EU. The ideal candidate will have great communication skills, excellent technical skills, exemplary attention to detail, and a passion for learning. This position will have the opportunity to make significant scientific contributions to numerous drug discovery projects.

Do you want to be part of an innovative, cutting edge technology, robotics company that is changing how BPH is treated? Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another? Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team. This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.

Works with and across the various disciplines of the engineering team, machine shop personnel, and assembly floor personnel for project realization, manufacturability, inspection, and assembly of product. One of the primary functions of the position is to create, develop, and establish cost effective processes and procedures for manufacturability, inspection, and assembly to reduce cost and improve fabrication methods that meet the product specifications and requirements across various projects.

We are looking for a highly motivated and detail-oriented RA II or Sr. RA to drive mammalian cell culture-based protein production workflows at Prolific. We are a team of scientists using light to control the expression of biotherapeutic proteins, increasing titer and improving quality attributes. We are rapidly expanding our capabilities in mammalian cell line engineering, stable cell line generation, and driving production runs to produce therapeutic proteins. You will be instrumental in optimizing and executing cell line development and protein production which will support multiple projects. Your responsibilities will include maintenance and engineering of mammalian suspension cell lines (including CHO), handling, seeding, and sampling runs for protein production, and contributing to downstream readouts such as Octet BLI, flow cytometry, and metabolite measurements (such as Nova). Your knowledge of mammalian cell line development techniques, combined with your attention to detail and motivation to learn will make you highly effective in this role. The ideal candidate for this role is energized by hands-on technical work and takes pride in owning and refining routine cell line generation processes for high quality results. You’ll get to work cross collaboratively with team members in optogenetics, synthetic biology, cell line development, hardware engineering, bioprocessing, and data science disciplines to establish cell lines crucial to Prolific’s success. This is a unique position and opportunity to drive cell culture workflows in an exciting startup setting. You’ll be provided with room for technical growth and receive mentorship to help you succeed. This role is based on-site in our headquarters in Emeryville, CA. The contract is expected to last for 6+ months with the possibility of extension or conversion to full-time employee at the end of the term.

We’re looking for an Electrical Engineer to support design, testing, and integration of electronic systems that power our advanced biomanufacturing platforms. You’ll collaborate closely with hardware, software, and bioengineering teams to ensure our electrical subsystems meet performance, safety, and reliability requirements. This role will be based on-site in Emeryville, CA and will report to the Senior Mechatronics Engineer of the company. Standard hours will be 40hrs per week, with the employee aiming to be onsite during the company’s core hours Monday-Friday, 10am-4pm.

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation specialists will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug product/etc. at client sites. The validation specialist will evaluate the equipment/utility/system/procedures used in development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have experience with current US and international regulations, guidance, industry best practice in one of the following areas of validation: facilities, utilities, and equipment qualifications, process validation, analytical method validation, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines.

Our Production Technician I – Formulation plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical product. Once you complete our training, your responsibilities will include supporting daily manufacturing activities for non-sterile and sterile bulk/CSP operations. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

The R&D Operations Assistant will work with technical product development on key projects for the R&D team.

Regeneron’s Bioreactor and Scale-Up Development Group within Preclinical Manufacturing and Process Development (PMPD) is looking for a motivated Process Development Associate to work as part of the late-stage development team to develop production processes of biologics in a non-GMP process development laboratory. In this role, they will perform studies at pilot scale to develop commercially enabling manufacturing processes.

Regeneron’s Cell Culture Development Group within Preclinical Manufacturing and Process Development (PMPD) is looking for a motivated Process Development Associate to work as part of the late stage development team to develop production processes of monoclonal antibodies in a non-GMP process development laboratory. In this role, they will perform studies at bench scale in support of clinical or commercial manufacturing production.

Regeneron’s Late-Stage Purification Development team within PMPD (Preclinical Manufacturing and Process Development) is seeking a full-time Process Development Engineer I. In this role, you will be responsible for the development and transfer of the harvest, affinity chromatography, and viral inactivation unit operations for recombinant proteins using Quality by Design principles.

We are seeking a highly motivated Associate Scientist to join the Non-Viral Delivery Technologies group within Regeneron Genetics Medicines. Our team works closely with all the other teams in the Genetics Medicines group to produce and develop lipid nanoparticles (LNPs) to support their programs. You will work on the LNP production core as well as conduct ligand targeted LNP development work.

The Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for supporting clinical studies, review of clinical trial protocols, supporting updates to IBs, ICFs, and authoring of DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.

At BioLegend we are dedicated to commercializing high quality reagents to support the research community for legendary discoveries. The Associate for BioLegend’s Quality Control group will test products such as antibodies and proteins in the following application(s): flow cytometry, immunohistochemistry, western blotting, ELISA, multiplex immunoassays and/or functional bioassays. The candidate will perform all aspects of the assays following SOPs and ISO requirements. Additional responsibilities include culturing mammalian cell lines, isolating primary cells, and maintaining laboratory equipment and supplies. We are looking for a highly motivated person who loves science and wants to be part of a dynamic and fast paced team.

The role of the Apheresis Operations Specialist I is to serve as a primary point of contact for both our donors participating in apheresis collections and our partner site contacts. The AOS I is responsible for screening and qualifying donors who are part of an extensive Sanguine database, and those who are identified by the Patient Recruitment and Marketing Team. The AOS I will screen potential donors to obtain the necessary health information, conduct medical record reviews to qualify donors for apheresis research studies, and provide a seamless experience for our donors. The Apheresis Operations Specialist is also responsible for collecting all necessary documents, coordinating with apheresis sites to schedule donors and pick up services, maintaining patient data and documenting results, fielding real-time calls and emails, and striving to provide a seamless experience for our donors. This individual will be a part of our Apheresis Operations team and will work cross-functionally with multiple departments including Project Management, Patient Operations, and apheresis site points-of-contact.

The Supply Associate position is responsible for assisting with the management of clinical supplies and equipment used in clinical studies. The Supply Associate is responsible for preparing and shipping study supplies to study participants and study staff, maintenance and accountability of study supplies and nursing equipment, ordering of supplies, and inventory management. The Supply Associate works closely with the Supply team, PI, sub-Is and study team to ensure safe and efficient conduct of clinical studies.

Serán BioScience is searching for an organized and detail oriented Associate to support the Sample Management Program within the Quality Control Department. The QC Associate I, Sample Management Coordinator plays a key role supporting sample coordination by managing sample inventory, including the receipt, handling, shipment, and storage of samples supporting the GMP retention program, stability program, and external Contract Testing Laboratories (CTL) testing. All necessary training provided. Those with an interest in starting a career in bioscience are encouraged to apply.

Position objective is to provide a high degree of direct support to end-user customers with the primary goal of ensuring on-going customer satisfaction. Accomplished by providing a high level of rapid and complete customer service through answering inquiries, problem resolution, customer communication and ensuring correct internal response to customer identified potential or actual issues which could impact the safety and efficacy of Nuclein provided products.

We’re looking for a highly motivated, flexible, and collaborative Research Associate with experience in, and a passion for—cell culture and process development. Based at our Bedford, MA location, you’ll contribute to developing and characterizing manufacturing processes for cell therapy products targeting cancer. You’ll be a vital part of a highly collaborative Technical Operations team, working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program, OBX-115—a novel engineered tumor-infiltrating lymphocyte (TIL) therapy.

The Cell Therapy Production Associate, Oncology plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.

A Cell Processing Associate assists in the performance of primary peripheral blood mononuclear cells (PBMCs) isolation from patient samples, as part of screening efforts for various customers. This position will help contribute to PBMC isolation process improvement, to drive efficiency in the documentation and production process. This role will support Process Development (PD) team efforts, and interact cross-functionally with teams that include, but are not limited to Business Development and Quality Assurance, to ensure company milestones are met. This position will ensure that products are processed under GLP practices, with appropriate documentation in place, it will also interact with external customers for which samples are processed, assuring that such communication is clear and disseminated in time, and processed samples are shipped back to customer, according to customer timeline.

Perform routine quality control microbiology activities in support of product production and releases. The position interacts with other internal departments, including Apligraf Production, PuraPly Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position may interact with external entities including contractors and suppliers. The QC Analyst I/II performs a wide variety of routine activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting result.

The Scientist I will contribute to laboratory operations by performing analytical testing, interpreting data, and maintaining laboratory equipment and documentation in accordance with established protocols and quality standards.

Responsible for providing advanced oversight of the analysis and administration of various quality policies, programs, and practices in accordance with current Good Manufacturing Practices (cGMP); provides feedback, direction and guidance to employees and management, using advanced professional and technical knowledge of quality or related equipment, testing, and procedures.

The Manufacturing Engineer is responsible for driving improvements across assigned value streams to meet Safety, Internal and External Quality, on-time delivery, lead time reduction, and Productivity. This role is a key part of the Value Stream leadership team, responsible for driving daily performance and leading data-driven, root-cause-based action plans to achieve breakthrough KPIs through LEAN (DBS) tools and continuous improvement. This position reports to the Operations Manager and is part of the Value Stream leadership team, located in New Port Richey, FL. It will be an on-site role.

This is a laboratory-based scientific role in a fast-paced, multidisciplinary team environment, requiring the utilization of biophysical analytical characterization techniques to support development of vaccine drug substance and drug products in a GMP-like environment. The vaccine drug substance and product development support includes sample manipulation, equipment maintenance, routine analysis, and characterization of development vaccines to support process and formulation development.

Metrology specialist is responsible for the oversight of regulated and non-regulated laboratory equipment. This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement.

We are looking to fill a Scientist 3 - Analytical Chemist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship.

As a Quality Control (QC) Associate I, you will work as part of the Quality Control team to test and verify that all raw materials and finished goods meet defined specifications for quality, consistency, and performance. In this role, you will test our manufactured products against established standards and release criteria, ensuring our customers receive high-quality, conforming reagents. We are looking for candidates who are highly self-motivated, eager to expand their technical expertise, and committed to their team’s success in a fast-paced environment.

Are you eager to build your career in pharmaceutical manufacturing while making a meaningful impact on product quality and patient safety? Join us at PCI as a Quality Associate I – Operations, where you’ll be on the front lines of GMP production—supporting real-time quality oversight, solving problems as they arise, and ensuring that every product meets the highest standards of safety, efficacy, and compliance.

The Plant Engineer I provides engineering support throughout the various manufacturing facilities in areas such as process equipment improvements, technological advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, safety and environmental regulation. Demonstrate good engineering, effective collaboration, partnering and teamwork skills when interacting with internal and external resources.

Facilities Engineer I estimates costs related to layout design, including equipment and materials, labor, etc. and monitors the construction process. Plans and implements the design of plants, offices, and production lines to maximize the use of available space and improve production efficiency. Ensure that established efficiency and safety targets are met. Research facilities equipment or fixtures for purchase and gather data relating to their ability to meet organizational needs. Works on projects/matters of limited complexity in a support role. Work is closely managed.

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production. Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business. Area of work involves manufacturing processes with interaction between production and cross-departmental engineering groups in resolving problems encountered on the production floor and across the business. Evaluates, selects, and applies exciting engineering techniques, procedures, and criteria, using judgment in developing and implementing adaptations and modifications on the production line and to quality systems.

Provide management in the engineering, design and development of new products or changes to existing products, processes, and equipment. Direct the transfer and scale-up of products from R&D to Production. Exercise judgment within generally defined practices and policies in determining project plans (milestones, resources) and selecting methods and techniques for meeting project goals.

As a key member of the Quality team, you will have a hand in ensuring that Penumbra's life-saving products adhere to the highest standards of quality and safety. In the Quality Monitoring & Improvement Specialist I role, you will be supporting our Quality Management System (QMS) processes, specifically Corrective and Preventive Actions (CAPAs), Nonconformance Reports (NCRs) and Deviation Authorizations (DAs) following Penumbra's procedures and regulatory requirements. You will organize and host board meetings to facilitate board review of documentation supporting these systems. You will also assist with data compilation for monthly trending meetings.

Perrig is currently hiring for an Associate R&D Process Scientist to lead scale-up of new infant formulas from development to full-scale production, overseeing change control, risk assessment, and factory trials while collaborating with cross-functional teams including Product Development, Pilot Plant, Operations, Quality, and Planning. Support manufacturing sites on continuous improvement opportunities in recipe and processing, driving optimization and renovation initiatives through root-cause analysis, cross-functional collaboration, and execution of cost-reduction strategies while ensuring compliance and operational excellence. Develop and implement new process capabilities via feasibility trials and continuous improvement projects to enhance efficiency, reduce costs, and improve overall product quality.

This role offers the opportunity to gain experience in a fast paced cutting edge clinical lab environment. The Sample Accessioner will work in a team environment which includes project managers and clinical lab ops specialists. As an Accessioner, daily tasks will involve patient specimen intake, accessioning and fulfilling client requests for returns or destructions. This will entail following SOPs and working with Laboratory Information Management System (LIMS) and other software. This role will also perform shipping / receiving, recording and inventorying of samples sent for laboratory testing.

We are seeking a motivated Associate Scientist to join our MSAT team, supporting the development, troubleshooting, and optimization of automated manufacturing processes for CAR-T and other cell therapy products. Under the guidance of senior staff, this role will perform bio-pilot run experiments, technology evaluations, and process improvement studies. The position will directly contribute to manufacturing robustness and efficiency by executing laboratory work, assisting in equipment testing, and analyzing process data.

The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

The Oligo Manufacturing Technician I is responsible for supporting Molecular Biology Conversion manufacturing in an ISO 9001 (Custom RUO) and/or ISO 13485 (DxGMP) regulated environment. This position performs production procedures in compliance with current Good Manufacturing Practices (cGMP) (ISO 13485), Standard Operating Procedures (SOPs), and applicable regulatory standards. The technician will work closely with cross-functional teams to deliver high-quality oligonucleotide products for research or diagnostic applications.

Performs initial, in-process and final inspections during manufacturing/packaging of product; resolves inspection findings with Packaging Manager and/or QA Manager. Collects product samples for product release testing, process validation testing and product stability as applicable and prepare labels at completion of packaging. Prepares documentation and forward samples to QC Lab for required testing; records information on batches in-process of testing on QC board; notifying QC of any urgent testing. Monitors incoming materials as received in Quarantine. Reviews material received paperwork and compare to material received for accuracy; notifying Materials Department to call supplier if CofA has not been received or CofA is incomplete. Coordinates with production areas to anticipate material usage to meet required schedule. Prepares required approval documentation for component or raw material inspection or testing. Collects raw material samples, label and forward with appropriate documentation to QC lab. Reviews lab data and approve/reject raw materials for use in production.

As a Technical Specialist, you will be an integral part of our dynamic R&D Laboratory. The ideal candidate will possess the ability to work collaboratively with our scientists and engineers to address and resolve a diverse range of technical challenges. The successful candidate will exemplify a strong commitment to the safe and efficient operation of our laboratories, which encompass both thermal processing equipment and sensitive analytical instruments.

The Engineer II, Validation understands validation methodology and can apply it to process, packaging, equipment, and cleaning activities. Generates and executes validation protocols with limited supervision. Adheres to validation schedules.

We are seeking an experienced Senior Research Associate I/II, Bioanalytical Sciences to join Mariana’s Preclinical Development organization, advancing personalized medicine and radiopharmaceuticals. This laboratory-based position will play a key role in conducting LC-MS-based bioanalysis to support pharmacokinetic (PK), in vitro ADME, and proteomics studies across preclinical programs, focusing on sample preparation, method execution, and data collection. The successful candidate will contribute directly to the development of novel therapeutics by generating high-quality quantitative and qualitative bioanalytical data.

The Validation Engineer I is an entry level position and will support the efforts of the Validation department.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

Join our team at MilliporeSigma as a Scientist 1 in Bedford, MA. In this role, you will be part of the Analytical team that focuses on the development, optimization and performance of analytical methodology supporting research and development of new products and their manufacturing processes. Your role will be to perform extractables studies, and to determine compounds that can be released or migrate from single-use and filtration devices and other MilliporeSigma products, using TOC, HPLC, GCMS, ICP, ion chromatography, LCMS, and other appropriate characterization techniques. This role will be lab-based, driving projects forward through innovation.

Primary responsibility is to monitor and support the Dry Powder Manufacturing process in Lenexa, KS. It is a 24/7 media manufacturing plant which requires round the clock support. The position is responsible for understanding the Dry Powder Media manufacturing process to include blending, pin milling, dispensing/packaging, and the cleaning/drying of the equipment. The incumbent will navigate the process control systems for the equipment and understand how the system interfaces and stores data to OSI PI historian. The engineer will have knowledge of product powder attributes such as particle size, bulk density, flowability, and cohesiveness. The process engineer is the liaison between maintenance, engineering, and the shop floor. Provide support and mentoring to other engineering and engineering support personnel. Assist operations implementation of process improvements and during equipment startup and commissioning activities.

MilliporeSigma in Bellefonte, PA is seeking an Associate Production Scientist. In this role you will manufacture or evaluate gas chromatographic (GC) capillary products according to established protocols, provide technical support to others, and perform operations in support of the group and department.

You will help ensure our manufacturing areas are meeting all pharmaceutical standards, including our aseptic environment. You will assist with collecting samples on critical utilities such as nitrogen, process air and the sites’ water systems. You will help with performing media fills including qualification and release in support of the environmental monitoring program. You will help with maintaining equipment and adhering to the sites Environmental Health and Safety program. You will assist with routine lab-related tasks and ensuring your work area is tidy to support audit readiness and bring issues to supervision immediately for escalations. You will also support QC in-process testing as a backup for weekend work.

As an Associate Product Engineer, with Moog Aircraft Group’s Electronics Operations Engineering Team, you will be assigned direct engineering responsibility for a variety of production programs. Work assignments require some originality and unreviewed action. You will receive program and technical guidance from the department supervisory personnel, project, senior product, or product engineers.

The Commercial Aircraft Electronics Group is looking for an Electronics Development Engineer to be responsible for the development and sustainment of Flight Control Computers (FCCs), Actuator Control Units (ACUs), and Motor Control Electronics (MCEs) for primary and secondary control systems for commercial aircraft.

May perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs and work instructions. Accurately collects and records raw data in logbooks and on worksheets. May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. May be required to perform required specific testing as applicable. May be required to operate specified laboratory equipment. May perform Environmental Monitoring, clean and disinfect cleanroom suites (required as applicable). Other duties as assigned.

The Lab Associate supports R&D labs by ordering, receiving, and storing reagents and materials. Upkeeps laboratory consumables and reagents inventory. Fulfills various requests by research staff related to laboratory workflows and anticipate laboratory needs.

We are currently seeking a Manufacturing Engineer to join our team at NeuroPace. The Manufacturing Engineer will support the development, documentation, verification, and ongoing manufacturing of products and processes required to produce an implantable Neuro-Stimulator and supporting lead systems.

The Quality Engineer will support the Quality Management System (QMS) to ensure compliance to FDA Quality System Regulation, ISO 13485 and other relevant Quality System Standards. The Quality Engineer will also participate in product development teams to provide design control quality assurance support to medical device development and validation efforts.

Work with manufacturing and engineering to ensure clear documentation, interpretation, and inclusion of customer requirements for assigned products. Support, plan, and implement activities concerned with development, application, and maintenance of quality standards for manufacturing processes, materials, products, and/or business systems. Develop, implement, and support standards and methods for inspection, testing, and evaluation relative to Nortech’s quality management standards to ensure products leaving the manufacturing or development organization are effective and free from defects or operational problems or errors. Review product, component, part, and assembly specifications, and develop and/or update testing-related documentation including test cases, plans, and flaw-reporting procedures. Work with training staff to ensure production and inspection personnel are properly trained. Support quality related issues such as interpretation of workmanship standards, manufacturing processes, customer prints, specifications and defect evaluations. Devise sampling procedures, design and develop forms and instructions for recording, evaluating, and reporting quality data. Develop and implement methods to ensure compliance of product development, documentation, manufacturing, and assembly processes. Maintain applicable quality records and perform quality audits in accordance with established standards. Compile, calculate, maintain, and report summary statistics required by customers. Inform product conformance decisions based on interpretation of quality data reports, SPC charts, and other applicable data; promptly notify management of concerns with potential to impact product volume, manufacturing lines, costs, or customer outcomes. Work with suppliers, customers, and internal departments on obtaining and/or responding to deficiencies and/or corrective actions. Coordinate the successful closure of closed loop corrective actions concerning quality issues of products and processes. Keep supervisor informed about project status, workload, concerns, questions, and progress. Demonstrate and support Nortech’s Mission, Core Values, policies and procedures at all times. May perform other duties and responsibilities as assigned.

We are seeking a highly creative, resourceful, and motivated Research associate to join our Protein degradation team. The ideal candidate will help us set up our in-house protein production capabilities and support our cell-culture and molecular biology efforts. Strong candidates will be independent, goal-oriented, and have excellent communication skills. We are seeking individuals who can be highly adaptable and comfortable working in a dynamic and fast-paced collaborative and multidisciplinary environment. This is a unique opportunity to drive the growth of an early-stage biotechnology company where you can meaningfully define the next frontier of protein homeostasis modulators. The successful candidate will play a key role in driving our discovery efforts aimed at developing therapeutic strategies that modulate protein homeostasis.

Join Helix's world-class, high-volume CAP/CLIA certified laboratory where transforming health organizations by weaving genomics into the fabric of healthcare. As a Lab Aide, you'll be at the forefront of our pre-analytical operations, working with a dynamic team that processes thousands of patient specimens daily. This role offers unique opportunities to challenge industry standards through innovative solutions. You'll gain hands-on clinical laboratory experience in a state-of-the-art facility while supporting the accessioning activities, plating procedures, and biohazardous waste program. With clear advancement pathways, you'll have the opportunity to grow from executing foundational tasks to becoming a subject matter expert and leader within the laboratory operations team.

As a Senior Electrical Engineer, you will design, develop, and evaluate electrical components and processes for our innovative breast and skeletal health products. You’ll be responsible for the physical layout of printed circuit boards, translating electronic schematics into reliable, manufacturable board designs, and ensuring compliance with performance and regulatory standards.

Are you passionate about ensuring the safety, reliability, and compliance of life-saving medical devices? At Hologic, we are seeking a Quality Engineer to support the design, manufacturing, and quality assurance of medical devices. In this role, you will apply quality protocols, perform inspections, investigate non-conformances, and drive continuous improvement initiatives to uphold our commitment to excellence. If you’re detail-oriented, eager to learn, and ready to contribute to a team focused on delivering high-quality products, we encourage you to apply and be part of our mission to improve lives worldwide.

The Electrical Engineer designs, develops, modifies and evaluates components and processes used in the generation, manipulation, transmission and storage of electricity. Determines design approaches and parameters. Analyzes equipment to establish operating data, conducts experimental tests and evaluates results. Selects components and equipment based on analysis of specifications and reliability. Completes documentation and procedures for installation and maintenance. May interact with users to define system requirements and/or necessary modifications. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.

As our Regulatory Affairs Associate, you will be an individual contributor responsible for analysis, evaluation, preparation, and submission of documentation for regulatory approval, ensuring Hyperfine products and procedures comply with US and global regulatory specifications. You will support our Regulatory team across different program areas, and will work on multiple projects concurrently.

The primary responsibility of the Manufacturing Specialist in Formulation is to weigh/dispense, setup/operate equipment to produce the bulk drug product for sterile manufacturing. They will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and work effectively with internal partners, clients, and vendors.

The Technical Services and Manufacturing Sciences (TSMS) Technical Transfer Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.

The Technical Services and Manufacturing Sciences (TSMS) Operations Engineer will provide direct technical support to manufacturing operations on the production floor in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will work closely with manufacturing operators and supervisors to ensure smooth production operations, troubleshoot technical issues, and support process execution as specified.

The purpose of the EM Technician I is to perform routine environmental monitoring to assess the viable and nonviable particulate levels within classified manufacturing rooms and support rooms.

The primary purpose of this position is to perform work which involves general engineering methods and tools. As an entry level engineer, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization.

The primary purpose of this position is to perform work which involves general engineering methods and tools. As an entry level engineer, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization.

The Process Development Associate I will provide process and analytical support to Tumor Infiltrating Lymphocyte (TIL) clinical and commercial development projects as part of the late-stage process development team. The successful candidate will have prior cell culture, process or method development, and cGLP/cGMP knowledge and experience. This role is a lab-based position, based in the Iovance Cell Therapy Center (iCTC) in Philadelphia, PA.

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for the quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations. Responsible for fostering site pride and J&J citizenship.

The Manufacturing Associate I/II will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Responsibilities include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves various unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration, and drug substance filling. Candidates must maintain process ownership, facility upkeep, and thorough documentation review to ensure compliance.The ideal candidate should have a basic understanding of cell culture, fermentation, or purification unit operations, with preference given to those experienced in single-use platform technology. Strong written and verbal communication skills are essential. The role requires an energetic, motivated, and dynamic individual who is highly organized and capable of maintaining efficiency and a positive demeanor in a fast-paced, multitasking environment

Join a highly technical analytical team in a dynamic work environment where you will participate in contracted client analytical programs as a member of the Analytical Development (AD) Department. The individual in this position will be responsible for executing experimental protocols and performing data analysis in biopharmaceutical laboratories.

Join an analytical team in a dynamic work environment where you will participate in contracted client analytical programs as a member of the Rapid Analytics team. The individual in this position will support biophysical characterization studies of biopharmaceutical products through executing experimental protocols, performing data analysis, documenting work in technical reports, and presenting results to clients and management. Biophysical testing may include (but not limited to) SV-AUC, CD, DSC, FTIR, HPLC, UV-Vis. Required to work in teams to solve scientific problems, and to train and be trained by colleagues.

The Microbiology Associate II will be part of the Microbiology Department responsible for the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. The position will be a first shift, 10-hour/shift position, located at the Hamlin Road facility. Responsibilities include laboratory support, program testing, reporting of results, execution of protocols.

Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years’ experience) or Engineer (3+ years’ experience) to support process validation planning, design, and execution. This person will be responsible for risk assessments, process improvements, investigations, and other projects. They will also play a pivotal role in technology transfer and ensuring processes transition properly from site to site.

The laboratory technician is responsible for sample processing and aliquoting. Process samples, including nucleic acid extractions, PBMC/BMMC isolations, plasma separation, specimen aliquoting, and other methods as required. Ensure sample integrity to meet client expectations.

Perform routine biochemical analyses for characterization of monoclonal antibodies in support of pharmaceutical development, including peptide mapping, A280, LCMS, size exclusion chromatography, fraction collection, or other routine methods. Sample preparation, distribution, and data collection, understanding of how to process data from chromatograms is a must. Reporting of data in accordance with requirements set forth by the department. Ensure maintenance of detailed documentation of assay development and qualification

Eurofins Discovery provides lab research services for pharmaceutical and biotech organizations in a wide range of therapeutic areas to promote novel therapies for patients in need. This role will conduct industry leading cell-based and analytical assays in a laboratory setting with automated and classical methods.

The Quality Assurance Assistant assists the Quality Assurance (QA) Manager during audits and client visits. Helps maintain reference data in LIMS and performs spot audits internally at the request of the QA Manager. Performs customer service requests for Project Management staff, supplies SOP's, certification information, and method information. Works with the laboratory to maintain SOP's and other method performance documentation as directed by the QA Manager.

This position is responsible for conducting routine microbiological testing, documentation, and data analysis, of utilities, raw materials, facilities and equipment. Additionally, the microbiology technician will be responsible for upkeep of the laboratory, laboratory supplies, and other various routine laboratory tasks.

Support existing qualification and Validation programs. Adhere to quality and regulatory compliance policies in support of GMP operations efforts.

The Clinical Laboratory Quality Control (QC) Associate (Tues - Sat and Sun - Thurs 10:00am - 6:30pm) performs and functions within the Technical Laboratory under the guided direction of the Supervisor, Clinical Laboratory Quality Control Lead, or designee. In this support position, the Clinical Laboratory QC Associate ensures daily QC operations are effective and efficient by coordinating with leadership to anticipate and resolve issues related to efficiencies in quality control, and laboratory processes.

This position will analyze and execute processes to ensure product quality in the Production Unit (PU). This position will support core quality system processes to ensure compliance with applicable medical device regulations and standards (FDA, EU, Health Canada, ISO 13485) by providing operations assistance, tracking quality metrics, reviewing and approving quality system records, and analyzing data. Requires working in a cross-functional team environment. Applies engineering principles to resolve difficult problems.

Responsibilities include supporting pilot line builds for formulated products, executing formulated products build plans, generating test data, assisting maintaining lab and pilot line equipment including 4-point probe, ellipsometer, FTIR, back up SEM/FIB and XRR operator, general lab assistance where needed.

The Production Technician 3 executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP) quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

The Manufacturing Support Associate performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

The departments of BioMolecular Research and Structural Biology, within the Protein Sciences Organization at Genentech are looking for a versatile, dynamic, and independent individual to contribute towards medium to large scale mammalian recombinant protein expression. In this collaborative role, the successful candidate will have the opportunity to work with other scientists and group leaders within and outside our department, driving projects autonomously to fulfill both straightforward and challenging protein production needs.

As a Manufacturing Engineer at the Hillsboro Technical Operations Fill Finish facility, you will be responsible for supporting the design, operation, control and optimization of manufacturing equipment at HTO. The position serves as an equipment, process, or automation owner and is engaged in development, qualification, data analysis, troubleshooting, and continuous improvement activities. The Manufacturing Engineer plays a key role in day-to-day operations, as well as design and delivery of local and major capital projects, and interacts with a cross-functional team to deliver on business objectives.

The QC Lab Support Contractor plays a critical role in supporting day-to-day quality operations within the cGMP QC laboratories. This role is responsible for overseeing all aspects of GMP lab supply management, documentation and record keeping, lab equipment maintenance, reagent preparation and general lab support. In addition, individual will ensure compliance with documentation practices and contribute to maintaining an organized and efficient laboratory environment. This position is based at our state-of-the-art facility in Lexington, MA.

The QC Technician contract role will be responsible for routine and non-routine QC sampling and testing for the quality of products manufactured for our clients. QC is responsible for execution of the Environmental Monitoring (EM) program in place to monitor Genezen's controlled manufacturing environments (cleanrooms) as well as monitoring of utility systems including Water for Injection (WFI), Pure Steam, Purified Water, Compressed Air and Gas systems. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter­departmental policies and standard operating procedures (SOPs). This position is based at Genezen’s state-of-the-art facility in Lexington, MA. This role supports daily operations as well as occasional weekend and holiday operations.

The position reports to the Associate Director, Downstream Viral Vector Process Development & MSAT Department. This role is ideally suited for a dynamic bench-focused individual to support/lead translation of research process to GMP-compliant manufacturing, and will develop, scale-up, and evaluate the technology transfer of viral vector processes. This is a great opportunity to join a fast-paced company, develop, and expand technical expertise to lead by example and potentially lead a small team in the near future.

Effectively design, develop, and document medical devices and medical equipment that satisfy internal and external customer needs and business objectives.

As a Sr. Research Associate, you will participate a multi-disciplinary drug discovery team through the design and synthesis of new molecules. The successful candidate will have an excellent track record and a commitment to tackling drug discovery challenges through organic synthesis.

An opportunity is available in the EH&S team at Gilead in La Verne, California. The successful candidate will be joining a highly motivated and cross functional team to help develop and elevate a proactive EH&S culture across our La Verne campus via administration of compliance related to our Sustainability and Injury and Illness prevention programs. You will use effective time management skills to work with limited supervision on routine projects to moderate complexity, including updating existing programs, protocols, and procedures. The Specialist will possess excellent communication and customer service skills and will be expected to maintain regular interaction with customer groups.

The Associate Quality Engineer will be responsible for achieving the highest quality level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. As a contributor to the quality engineering organization, this professional will be a self-motivated and characterized as an excellent problem solver. This person will play an integral role in maintaining

The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations.

We are seeking an innovative and highly motivated Cell Therapy Manufacturing Specialist to join our Process Sciences team who will contribute significantly to the development and manufacture of our advanced cell therapy manufacturing platform. The primary focus of this position will be to support manufacturing operations, as well as day-to-day lab operations. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Cellipont Bioservices is growing, and we are looking for a Manufacturing Associate I who believe in the potential bridging client's discoveries to patient cures and who want to challenge the status quo and take Cellipont and its clients to the next level. The Manufacturing Associate I is an entry level role and will be responsible for assisting in the planning and timely execution of manufacturing operations for a cGMP-compliant state-of-the-art cell processing/clinical manufacturing facility with emphasis on primary cell isolation and cell culture in an aseptic processing environment. The Manufacturing Associate I is responsible for following the standard practices outlined for the operation of the facility in accordance with the regulatory requirements for the manufacture of materials for our clinical studies, clinical trials and products.

Cellipont Bioservices is growing, and we are looking for a QA Technician II, Operations who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The QA Technician II, Operations will be responsible for monitoring systems and procedures to ensure compliance where applicable. The QA Technician II, Operations is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks. This individual will be responsible for providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed.

We are looking for a Laboratory Technician to join our R&D team in Palo Alto. The role is part of a small group that divides their focus between innovative new projects and product development. The ideal candidate will be extremely organized, familiar with basic laboratory techniques, and excited to learn and grow within the team. Technicians will divide their time between hands-on laboratory work, data analysis, and lab organization and maintenance. Candidates with knowledge and experience of PCR, library preparation, NGS sequencing or RNA seq will be given preference.

Perform cross-functional laboratory assays with a focus on synthesis and purification of radiolabeled compounds and their characterization. Assist in the development and execution of novel assays including collecting and processing data.

The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays, such as enzyme-linked immunosorbent assay, to measure large molecules and their immune responses. The main types of assays include Pharmacokinetic assays to measure drug and Immunogenicity assay to measure anti-drug antibodies and neutralizing antibodies. Other assay types also performed are branched DNA and cell-based assays. An array of platforms are used to support these assays that include spectrophotometer, Meso Scale Discovery, Luminex and Gyrolab. Utilizing these platforms/assays, the teams are responsible for the method development, validation and routine sample analysis in both the regulated and non-regulated space of non-clinical and clinical studies.

A Technician I is in training to perform and become proficient in on-boarding tasks, procedures, and cooperating in a team environment. The technician is learning basic tasks required to conduct a study, which may include collecting and recording data in the performance of studies. Responsible for handling and restraining animals, clinical observations, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. The technician is working under close supervision to gain proficiency

Perform laboratory tasks by various basic methods. Generate and record data with minimal supervision in the performance of studies. Responsible for handling and processing samples and performing accurate data collection and reporting.

Responsible for the coordination of supportive equipment and process validation activities such as testing, calibration, scale-up, engineering and validation studies, and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.

Quality Control Lab Technician I role at Cord Blood Registry (CBR) is responsible for analyzing and documenting test results from our cord blood and cord tissue processed samples, releasing raw materials, supporting the analytical and processing equipment maintenance program, conducting environmental monitoring, and providing a wide range of critical functions that support the cryogenic storage of our client's final product. This position is also responsible for providing our internal customers with technical expertise while maintaining the highest quality services possible. The Quality Control Lab Technician I directly supports manufacturing to ensure the Product Operations function is provided with adequate equipment and materials to support stem cell processing activities. At the Technician I level, the individual performs critical daily activities involving high complexity testing, equipment maintenance and troubleshooting, interfacing with service providers, reagent testing, executing quality control assays and environmental monitoring activities. The role is also involved with supporting and executing validations, verifications, and projects within the Quality Control department.

As a Development Engineer, you will play a hands-on role supporting the design, testing, and improvement of systems that produce and distribute radiopharmaceuticals across the U.S. The Development Engineer is responsible for specific tasks and overall objectives to meet and exceed team and personal goals while managing multiple projects under general guidance. This role also conceptualizes project paths quickly and accurately, is a problem solver, and addresses challenges strategically and efficiently.

The Production Technician I is responsible for the aseptic manufacturing of Cresilon’s products for the animal health industry. The Production Technician II will be trained in clean room operations, aseptic techniques, and must demonstrate the ability to successfully pass gowning qualifications. The position involves operating simple and complex processing equipment, routine sanitization of cleanroom facilities, and manual cleaning of equipment. The ideal candidate will have a proven track record of steady progress in a similar manufacturing environment and must possess a willingness to learn all equipment and jobs in the assigned manufacturing and sanitation of clean room facilities as required. Production Technicians are also responsible for the quality of products produced by ensuring compliance with local, State and Federal regulations, including current Good Manufacturing Practices (cGMP).

Key responsibilities include conducting computer system validations to ensure adherence to GxP regulations, including 21 CFR Parts 210, 211, and 820, as well as compliance with Good Automated Manufacturing Practice (GAMP) standards. Ensures that change controls, records, and procedures align with current Good Manufacturing Practices (cGMP) and regulatory expectations. Coordinates validation activities with cross-functional teams to minimize impact on production schedules while ensuring timely execution. Responsible for authoring validation protocols, final reports, and technical summaries for the qualification and release of equipment, systems, instruments, components, and utilities. Support continuous improvement initiatives and provide mentorship to junior validation staff.

The principal responsibility of Quality Control Lab Technician I is the analysis by multiple procedures of intermediates and target compounds. This role is expected to demonstrate expertise in both the theoretical and practical aspects of analytical chemistry. A major component in the scientist's performance rating will be based on productivity. In general, the Quality Control Lab Technician I provides technical, organizational and compliance support for 170+ ongoing stability studies. The incumbent is encouraged to display a degree of professionalism reflected in part by increasing the scientist's knowledge of theory and practice through reading scientific journals and texts at times beyond the "normal" working hours.

The Electrical Project Engineer is responsible for the Design, Implementation, and Qualification of membrane manufacturing equipment (electrical portions). This includes component and vendor selection as well as contractor supervision.

The Sensor Process Development team provides global ownership and supports sensor development and manufacturing. As part of the Operations organization, the team ensures process modernization and improvements for sensor safety, sensor accuracy, and sensor reliability resulting in positive outcomes for our users every day. The team has expertise across many subject areas and experience levels, leading to a collaborative environment with innovative solutions. This role will support technical projects related to sensor process development and provide expertise in design and understanding process impact on sensor performance.

DiaCarta is seeking a highly motivated, independent, and interactive Research Associate to join the R&D function in the company. The new team member will participate in R&D activities with the goal of developing and launching new qPCR, NGS, and branched DNA tests for IVD cancer diagnostics applications. The successful candidate will have outstanding attention to detail, enjoy working in a fast-paced multidisciplinary team environment, and have exceptional hands-on laboratory skills. DiaCarta is a rapidly growing company, so the candidate must be highly motivated and committed to launching their career in an innovative area of molecular diagnostics. This is a full-time role in Richmond, and you will be reporting to the Senior Scientist.

A PBMC Laboratory Technician will be responsible for conducting special laboratory procedures for clinical trials performing high complexity laboratory techniques including, but not limited to routine isolation of peripheral blood mononuclear cells (PBMC), or other laboratory procedures, etc., ensuring safety measures are followed by facilitating laboratory operations.

We are seeking a detail-oriented and proactive Quality Specialist to join our Quality Department in Austin, TX. This fast-paced role is ideal for someone passionate about quality systems, metrics, and continuous improvement. You will play a key role in supporting and managing quality processes including Field Actions, CAPAs, SCARs, and NCMRs, ensuring full compliance with internal procedures and regulatory standards. Reporting directly to the QMS Manager, this position is responsible for maintaining and reporting critical quality metrics that reflect the overall health of plant operations and production/quality controls. These metrics are regularly shared with senior leadership and cross-functional teams to drive performance, accountability, and compliance across the organization.

At Enveda, every role drives impact. As a NMR Scientist, you’ll be at the forefront of delivering hope to patients everywhere. Your expertise in NMR spectroscopy, instrument maintenance and structure elucidation will be critical in accelerating our mission to advance our pipeline of novel small-molecule therapeutics because every breakthrough starts with bold questions and brave actions.

The Staff Design Transfer Engineer will be responsible for designing and developing complex medical devices from concept to production, ensuring they exceed customer expectations. You will be expected to work directly with customers to understand product needs, define process specifications, develop manufacturing processes, and build and test devices to those specifications. This role will focus mainly on the processes and fixtures required to consistently manufacture endoscopes. This role collaborates early in the concept phase to guide the team toward manufacturability and repeatability of a design. This role is expected to bring relevant experience to the team and improve the design or process to exceed our customer expectations.

We are seeking a detail-oriented and motivated Quality Control (QC) Analyst. This role will support the quality of our products. This position must prioritize lots to ensure schedule and goals are met. Responsible for ensuring performance testing meets data specifications. Perform all duties using safety conscious practices. This is an excellent opportunity for individuals passionate about quality and continuous improvement within a manufacturing industry.

Formulates products and intermediates utilizing biologicals and chemicals of varying properties and characteristics in order to meet specifications

BioRestorative Therapies, Melville, NY is recruiting for a cGMP bio-manufacturing engineer. This role provides outstanding opportunities for talented self-motivated individuals, ideally with experience in (stem) cell biology, immunology, and/or molecular biology, who can contribute to our ongoing efforts to generate clinical grade cell-based therapeutics. We are most interested in connecting with qualified individuals who aspire to support the development of therapeutics and/or life science products and tools to support research endeavors.

Performing routine quality control testing of stem cell products using protocol-defined assays to demonstrate their activity. The assays include culturing and handling of stem cells, primary cells, and basic cell lines for use in flow cytometry and immunocytochemistry (ICC). The position requires routine documentation, data analysis and good communication of results. Good Manufacturing Practice (GMP) documentation and workflow is required. Other duties include instrumentation maintenance, reagent preparation and routine lab support for QC antibody testing using western blot, simple wes and immunohistochemistry.

The Bioassay Quality Control department provides team members the opportunity to practice and learn a variety of laboratory techniques. This position is responsible for performing protocol-defined bioassays on proteins and antibodies to demonstrate the activity of a product. The position requires maintenance of cell lines and isolation of primary cells for use in the assays. Good Manufacturing Practice (GMP) documentation and workflow is required in this position.

This position is responsible for ensuring that equipment, systems, and processes are qualified and validated in accordance with regulatory requirements and BioSpectra’s standards. This includes developing, executing, and reporting on equipment, instrumentation, and control system qualifications and re-qualifications

Quality Engineer II will be a key member of the Nitinol Shape Memory team supporting the self-expanding component product lines. This role will partner with representatives from the Manufacturing Engineering and Production functions. The person in this role will take the lead in addressing quality issues in a dynamic production environment. The ideal candidate will be comfortable interfacing with downstream internal customers and providing quality leadership to a production team running across 4 shifts.

Our Associates perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative, intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible, with the ability to work effectively and efficiently on a team while demonstrating safety, quality, and GMP compliance at all times.

The Associate Scientist is required to possess mechanical aptitude and the ability to perform tasks involving manual work. While supporting personnel are available to assist with material handling and equipment setup, the Kilo Lab Associate Scientist is responsible for overseeing and conducting batch activities. Typically, the Kilo Lab handles processes ranging from laboratory-scale up to 200L vessels. This facility serves as a testing ground for new manufacturing technologies, such as flow chemistry and emerging methodologies, in which the scientists frequently participate.

The Specialist, Associate Process Engineer, Cell Therapy provides technical support to the Devens Cell Therapy Facility (CTF) Manufacturing processes in a GMP environment. Technical support includes troubleshooting process and equipment related issues that occur during the Manufacturing process. The Associate Process Engineer works closely with the Manufacturing and Quality teams to determine immediate corrective actions for deviations, identifies root cause, and implements long-term preventive actions. Other responsibilities include participation in process tech transfer, supports incoming process changes by communicating the changes to applicable departments, and participates in process improvement projects at the site. The process engineer works to identify and drive continuous improvements to the manufacturing process.

The Bruker AXS-EM division is looking for an electromechanical technician to do board level debugging of PCBs on our electron microscope products. Bruker AXS-EM electronics span a wide range from high-speed digital cameras and scanning systems to ultra stable precision current supplies to 200kV high voltage supplies with tens of millivolt stability. The successful candidate will be able to handle multiple projects simultaneously, making sure that things come together in a timely manner. Help others as needed. Responsibilities will shift and grow based on ability and interests. Light travel to Asia and Europe is a possibility but not a requirement.

Snapdragon Chemistry is currently seeking exceptional candidates to join the Engineering and Manufacturing team in Waltham, MA. A successful candidate will be joining a group of innovative and entrepreneurial engineers and scientists, with broad deliverables including the development of reactor systems and purifications for continuous flow processes, delivery of high quality, complex chemical matter to our clients, and transferring process technology to clients at their facility. The ideal candidate will have a degree in chemical engineering with experience and a passion for developing new process technology. The candidate should enjoy building equipment and carrying out process development and manufacturing activities in a laboratory or kilo-laboratory environment. The candidate should be well versed in process development and scale-up activities, including common reaction, separation and purification techniques, such as working with 10-100L batch reactors, liquid-liquid extractions, vacuum distillation, filtration, and crystallization. Experience with the development of reactions in flow is preferred but not required. Candidates must possess strong written and oral communication skills.

As a Manufacturing Associate I/II, you’ll be a vital part of Capricor’s efforts in delivering therapies for patients in need. Supporting critical clinical trials and exosome development, you’ll perform meticulous production tasks and documentation to uphold our quality and compliance standards. This role places you in a cleanroom environment, where precision and attention to GMP standards are essential. You’ll be instrumental in ensuring that each production step is performed with accuracy, ultimately contributing to Capricor’s therapeutic success.

The Molecular Technologist – Solid Tumor is responsible for performing various high complexity molecular techniques that include but are not limited to nucleic acid extractions and next generation sequencing (NGS). This position works under the direction of the supervisor and follows standard laboratory procedures and policies.

A typical day for the molecular technologist includes RNA extraction utilizing a mixture of manual and automated methods, RT-PCR performed via manual pipetting, and sample loading on array chips for final result determination. The technologist would be working with equipment setups for all processes, as well as reagent preparations, specimen management, and assisting with inventory and quality management tasks as needed. This role will spend the most time on specimen management and preparation, in-house control creation and reagent Q.C. testing, and quality control checks and documentation associated with high complexity clinical laboratory testing.

Catalent Pharma Solutions in Kansas City, MO is hiring Controlled Substance Specialist II. The Controlled Substance Specialist II will support the state of DEA regulatory compliance of controlled substances at the KCM site through the following: oversee the inventory and other aspects regarding the use and storage of controlled substances in pharmaceutical dosage forms in development, laboratory, manufacturing, and packaging environments. Support all necessary regulations with DEA 21 CFR 1300 to end, Bureau of Narcotics and Dangerous Drugs and state licensure, state reporting and maintaining NABP Drug Distributor Accreditation.

The Engineer, Manufacturing Sciences and Technology (MS&T) is responsible for supporting GMP manufacturing operations as a project leader to commercialize new products and optimize commercial manufacturing processes. The Engineer, MS&T assists in translating client and process development information into cGMP process implementation.

The Project Engineer I will assure projects are executed in accordance with current site methodologies, policies, industry best practices, and cGMP requirements. The role will leverage the knowledge of GMPs and manufacturing processes to ensure that projects are executed with minimal disruption to operational schedules and must provide construction management oversight to ensure that projects are completed safely, efficiently, and in accordance with all applicable codes and requirements.

Celerion is hiring a Scientist/ Associate Scientist of Laboratory Automation to join our Lincoln, NE Bioanalytical team. This role will work onsite daily with our Hamilton, Tecan and Sciclone instruments. In this role, you will perform research and/or development in collaboration with scientific teams and automated systems based on new and existing methodologies. This hands-on role focuses on programming and operating laboratory automation systems with the objective of becoming the subject matter expert for all laboratory automation technologies within our organization.

Perform routine quality control testing of protein, peptide or antibody products using standard operating procedures to determine lot status, product release and product stability. Tests include: concentration determination, SDS-PAGE with densitometry, endotoxin assay, TOC, conductivity and other testing as assigned. The position requires routine documentation, analysis and communication of results within the department and across different groups. Other duties include instrument calibration and maintenance, record keeping, and lab support. Within this job function, the Research Associate must also pursue annual goals that aim to facilitate innovation, efficiency, productivity and team building across the QC Department or the entire company. Perform additional duties as assigned.

This position is responsible for performing small scale cell culture to produce GMP and non-GMP recombinant proteins and monoclonal antibodies for growth in various types of bioreactor systems, reviewing previous batch records to optimize growth conditions for production, media and supplement preparation, and additional duties as assigned. This position requires weekend work with a Tuesday to Saturday shift.

Answers and documents incoming customer inquiries by phone, email, and chat. Meets with customers via video conference – Teams, Zoom, Webex, etc., as needed. Addresses inquiries on instrument and software operation, product selection, techniques, procedures, and performs simple troubleshooting. Initiates complaints and works with the appropriate team(s) to resolve. Documents communications and resolutions in Salesforce (CRM, Customer Relationship Management Database). Provides adequate information to the Scientific Support teams to problem solve or to assist with resolution of issue. Communicates with Scientific Support Team, Customer Service, Field Service and Applications, and Sales teams regarding ongoing cases and issues. Documents information and recurring technical issues to support product quality programs and product development. Assists Scientific Support in department functions/projects including but not limited to the maintenance of technical resources, training materials, and FAQs. Supports Marketing and internal teams by providing Voice of Customer. Initiates replacement orders if required by complaint. Is aware of Field Notifications and required actions. Keeps up to date on current technology and use of product lines by attending seminars, reading current scientific literature, and using products in lab. Keeps up to date with training and reading Standard Operating Procedures (SOPs). Follows company policies and practices as outlined in Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene, and Exposure Control manuals in accordance with the job. Performs additional duties as assigned.

Under routine supervision, primarily responsible for the enhancement of existing products on our sustaining team. Involved in creating concepts and modeling and drafting designs utilizing 3D CAD software. Other responsibilities include drafting of design history file documents, development of test plans to assess designs, and assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project.

Carry out Molecular Biology, Microbiology, and Protein experiments following established SOPs and/or the guidance of laboratory management. Perform DNA/RNA extraction, quantification, and gel QC. Perform PCR setup for qualitative and quantitative analysis. Report experimental results to project managers in a timely manner. Follow established quality management policies and GLP and GMP practices.

In this role, you will report to the Onsite Supervisor and will work closely with the Avantor’s Advanced Laboratory Services professionals to serve our customers by performing customized, mission-based lab work and research protocols that help return time back to science.

The Research Associate, Process Development Downstream will provide laboratory support for Process Development by assisting in the downstream process and/or method development. The Research Associate may be assigned various tasks within the department and outside the department as needed.

The Quality Engineer, Failure Analysis will be responsible for investigating complaints, internal non-conformances, and collaborating with various teams to ensure thorough investigations of product hardware and software issues. This role will be responsible for generating failure investigations reports, metrics and data analysis.

The QC Microbiologist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.

The Microbiologist I conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.

The Sample Control Technician is responsible for ensuring that all samples are entered into the Laboratory Information Management System (LIMS) and made available to the lab staff in a timely manner. In addition, this position will manage lab inventory, including but not limited to tracking, shipping, and receiving of materials. As needed, this individual will coordinate and assist the metrology department in calibrations and equipment. This position reports to the Associate Director, Microbiology.

Conduct microbiological analysis on raw materials, solution, and components following approved Standard Operating Procedures in an accurate and timely manner.

Responsible for performance and efficiency of Analytical Validation and Qualification activities. Lead and/or coordinate activities in support of analytical validation operations to ensure safe operations, effective planning, and regulatory compliance in the performance of method, process, cleaning, and stability validations for various chemical products while maintaining high standards for quality and responsiveness to production requirements.

Responsible for endorsing process and product quality, efficacy, and safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products.

We are looking for a dynamic R&D Engineer III to support the growing TheraSphere Y90 franchise. In this role, you will make important contributions to support new product development and exploratory initiatives on the TheraSphere Y90 R&D team. This role offers a unique opportunity to work on a global team developing innovative technologies in the field of interventional oncology!

We have an exciting opportunity for an Electrical Engineer I, focusing on New Product Development (NPD), Sustaining, and Compliance on the Coronary Therapies team within the Interventional Cardiology (IC) division here at Boston Scientific. This role will utilize a variety of new and proven technologies to deliver life-changing medical devices to patients and clinicians in support of BSC’s mission.

The Quality Assurance Engineer I is responsible for Quality Assurance support for Instrument Manufacturing. This position reports to the Quality Manager and is part of the Instrument Mfg. Quality Assurance team located in Chaska, MN and will be an on-site role.

Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents). Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required. Provide technical collaborate with FDA and international reviewers and respond to questions. Provide timely review and approval of product labeling and marketing claims for regulatory compliance. Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations

The Biochemist II, Beads Manufacturing must have working knowledge of fluorescence microparticle manufacturing. This role will conduct data analysis to solve complex problems with various factors. The Biochemist II is responsible for improving process efficiencies and product quality. This position will also support and participate in continuous improvement projects as identified by the leadership team and assigned by the Manager.

The Bioreagents Formulator position plays a vital role in the manufacturing and quality process by preparing high-precision reagents and buffers that power our diagnostic testing platforms. This individual will be responsible for the formulation of PCR master mixes, process controls, and large-scale buffers that are later integrated into test kits by our production teams. Accuracy, consistency, and adherence to quality standards are essential as the materials produced directly support our customers’ ability to deliver reliable results to patients worldwide.

The Scientist II (Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing in addition to other key methodologies such as KF and titration. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company) and may also assist with method development / method validation projects.

As a Building Automation Engineer, you will be trusted with the design, implementation, and optimization of advanced building automation systems (BAS) across our manufacturing campus. You will work with Johnson Controls (JCI) platforms to integrate HVAC, fire, security, and energy systems, ensuring operational efficiency, regulatory compliance, and environmental control at our Manufacturing Facility in Houston, TX.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Sr. Associate, Mechanical Design Engineering supporting Alcon's Engineering function, you will be trusted to work on developing innovative intraocular devices and improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Sr. Associate Controls Engineer supporting the U.S. MTO Team in Johns Creek, GA.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Senior Engineer, II supporting mechanical design projects by tackling complex mechanical design tasks, refining components, conducting performance analyses, and troubleshooting. You will be expected to build effective and meaningful relationships with engineering teams and apply advanced modeling and simulation techniques.

QC Analyst I must have broad knowledge of microbiology techniques within the laboratory required for the routine support of the microbiology laboratory operations. In this role the Analyst will be a fully functional member of the team responsible for testing and data entry for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment

Senior Formulation Scientist will be responsible for the formulation development for small and complex molecules, including controlled-release, liposomal, and spray-dried dispersions (SDD). This role requires deep expertise in oral and advanced formulation technologies. The scientist will evaluate innovative drug delivery approaches and support development from preclinical through late stage. This position collaborates closely with manufacturing and analytical teams to ensure successful technology transfer for GMP manufacturing.

You will assist in daily activities and operation of the Laboratory Sciences department including equipment maintenance, stocking supplies and general cleaning. You will also support and perform data collection activities including primarily focused on mass-spectrometry.

In this vital role you will be responsible for sampling, inspection and dispositioning all raw materials received at the facility under general supervision. A key aspect of this role is to apply critical thinking skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include batch record review, SOP creation & review, documentation, review & approval of minor deviations and CAPA records and batch disposition of raw materials.

Let’s do this. Let’s change the world. In this vital role you will provide testing support for the QC Night Shift“Team C”(Saturday - Tuesday from 9:45pm – 8:15am)at Amgen Rhode Island.

The Automation Engineer's primary role is to work under supervision and coordinating installation, troubleshooting and assist in maintaining automated processes and facility related equipment.

As a Document Control Engineer I, you will be responsible for working within the framework of a team and performing the following activities: Understand and comply with Applied Medical's Quality Systems (QS), safety rules, and company policies. Coordinate and respond to questions and act as a liaison to internal and external customers/ Review, monitor, and approve programs and documentation, as assigned, to ensure compliance with relevant standards, regulations, and guidance documents. Work with Systems, Applications & Products in Data. Processing (SAP) system to understand and maintain material masters, bill of materials (BOMs), and routers. Maintain and improve internal document procedures. Identify and implement systems to improve the overall efficiency of processes within Document Control/ Perform additional duties and responsibilities, as needed

Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.

This person will be involved with coordinating and managing the Quality Assurance activities in all areas of the production/manufacturing processes. This will consist of ensuring quality standards are met in the manufacturing of products. This person must be able to effectively communicate vital information to various personnel throughout the organization.

Under the supervision of the laboratory supervisor the Microbiologist I provides a high level of quality pharmaceutical microbiology testing as well as effective customer service to ARL Bio Pharma clients. This is a safety sensitive position as defined by state and federal laws that will require working with hazardous materials and/or handling medicine.

Are you ready to dive into the world of Analytical Sciences within GMP regulations? Join our dynamic team responsible for supporting clinical stage biopharmaceutical products. We manage lot release and stability programs, reference standards, critical reagents, and more. Collaborate with experts across multiple analytical disciplines such as chromatography, electrophoresis, immunoassay, bioassay, and device functionality methods. Work closely with Analytical Sciences development personnel, Clinical Supply Chain, CMC, and Quality Assurance throughout all stages of clinical development.

We are seeking a highly motivated and independent Scientist to join our rapidly growing Cell Therapy Team. In this role, you will contribute to advancing innovative Cell Therapy products by designing and conducting laboratory experiments, developing methodology, and generating and interpreting scientific data in a highly collaborative environment.Expertise inin vitro and in vivo studies and T cell biology is critical for this role. To be successful in this role, you must be well-organized and keep an excellent written record of your work. You will be based in Gaithersburg, MD and report to the Associate Director, TCR-T Cell Therapy.

Understand and follow appropriate standard operating procedures and work instructions. Regulatory awareness of chemical handling and hazards. Labeling. Safety procedures. Department specific SOP’s. Proper use and basic equipment maintenance. Follow priorities from supervision. Document results, process, and refer to past batch records. Complete all compliance trainings as assigned. Participate in continuous process improvement efforts. Works independently with minimal supervision on routine tasks. Ability to support and help others in the team. Knowledge of work performed by the department and learning how to perform multiple functions within the department. Flexibility to work on multiple tasks with increased effectiveness. Primary operator of manufacturing equipment, including equipment changeovers. Understand and repair minor mechanical issues with manufacturing equipment. Assist in training of new and temporary hires in the Manufacturing Department. Assist with equipment pack line or manual pack line operations. Identify process improvements and flag areas for improvement. Meet quality and productivity expectations. Manages time well and will put in extended time as needed. Willingness to accept changes in work from day-to-day within reasonable and expected boundaries. Perform other duties as assigned within and outside the department.

Performing routine quality control testing of stem cell products using protocol-defined assays to demonstrate their activity. The assays include culturing and handling of stem cells, primary cells, and basic cell lines for use in flow cytometry and immunocytochemistry (ICC). The position requires routine documentation, data analysis and good communication of results. Good Manufacturing Practice (GMP) documentation and workflow is required. Other duties include instrumentation maintenance, reagent preparation and routine lab support for QC antibody testing using western blot, simple wes and immunohistochemistry.

The Bioassay Quality Control department provides team members the opportunity to practice and learn a variety of laboratory techniques. This position is responsible for performing protocol-defined bioassays on proteins and antibodies to demonstrate the activity of a product. The position requires maintenance of cell lines and isolation of primary cells for use in the assays. Good Manufacturing Practice (GMP) documentation and workflow is required in this position.

Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate must have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, including immunoassays, chromatography, spectrophotometric techniques, light scattering, and particle sizing. Experience in analyzing vaccine and adjuvant-containing formulations is a plus. In addition, Vaxcyte is looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a lab-based scientific role and requires excellent scientific judgement, independence, rigor, and thorough record-keeping.

Supports the development of upstream or downstream production processes for cell therapy projects. Supports technology transfer to CMO and provides manufacturing support for GMP production. Supports a fully integrated team to facilitate the success of projects. Utilizes understanding of principles of molecular and cell biology techniques when troubleshooting typical problems. Applies statistical principles to guide process optimization. Conducts cell culture experiments, characterization and data analyses in support of process characterization and improvement. Supports technical reports, regulatory filings, source documents, patents and external publications. Works within departmental teams, supports deliverables and participates in team discussion on issue resolution.

Performs and documents the analysis of samples following approved test methods. Calculate, check, and/or review data. Assist with method development, validation, and transfer. Assist with instrument calibrations and maintenance. May work on analytical projects under direct supervision. Attend training classes and seminars as required.

The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.

This role is key to developing and introducing process improvements, standards, life cycle management and validation in select process areas, helping to advance and transform West’s growing business, supporting capital investments and contributing to addressing complex assignments. This person has decision rights for his process area, and he/she will have the opportunity to drive the implementation of new innovative processes and technologies in cooperation with the engineering and quality assurance teams and the plants.

The Process Equipment and Reliability Engineer I will provide technical support to ensure safe, reliable, and compliant operation of process and utility equipment within a biopharmaceutical manufacturing facility. An Engineer I, will assist with troubleshooting, preventive maintenance, and reliability initiatives while working within cGMP requirements, engineering systems, and reliability methodologies. This role is designed to build foundational skills in equipment engineering and reliability while contributing to daily operations and long-term asset improvement efforts.

This Software Engineer I position is on the Digital Health Engineering team in Abbott’s Cardiac Rhythm Management division, and works on-site in Sylmar, California. The Digital Health Engineering team is responsible for developing, maintaining, and leveraging software solutions to provide internal and external stakeholders with the data and resources they need to effectively manage patient care, optimize clinical therapies, and improve product performance. Members of the Digital Health Engineering team are expected to translate complex customer and business needs into data-driven technical solutions. This role requires a blend of strong technical and software engineering skills, problem-solving abilities, customer centricity, as well as creativity, strong communication skills, and an entrepreneurial mindset.

The Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Design and conduct experiments for process optimization and/or improvement. Appropriately document experiment plans and results, including protocol writing and reports. Lead process control and monitoring of CTQ parameters and specifications. Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). Lead the investigation, resolution and prevention of product and process non-conformances. Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member). Lead in the completion and maintenance of risk analysis. Work with design engineering in the completion of product verification and validation. Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Ability to effectively communicate, facilitate and organize project activities relating to ensuring supplier quality. Develops and manages project schedules to ensure deadlines are met. Serves as the primary Quality contact for suppliers and provides technical assistance to management for suppliers as requested. Works with supplier development engineering to performs on-site annual and critical component supplier audits to ensure compliance with Quality Systems procedures and CSI requirements. Generates audit reports and ensures supplier audit findings are tracked to timely and closure. Provides quality systems input to suppliers such as, but not limited to: statistical process control, gage R&R studies, and capability studies. Resolves supplier quality issues at incoming inspection and the production line. Provides project team leadership and conducts investigations relating to supplier quality issues. Completes non-conforming material reports (NCMR), supplier requests for change (SRC), supplier corrective action requests (SCARs) and monitors follow-up with assigned supplier base. Routinely reports on supplier performance per defined metrics to management and other team members. Represent Quality during audits and interface with FDA, ISO, or any external auditor.

The Cell Line Development Group in South San Francisco, CA is seeking an Associate Scientist II to join a talented and collaborative team developing CHO cell lines for GMP applications. In this laboratory position the candidate will perform hands-on CHO cell line development for pipeline assets and support the establishment of automation capabilities in the group to increase throughput. The successful candidate will contribute to the evaluation and implementation of an automated liquid handler for cell culture workflows.

The Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position supports the maintenance of the quality systems in support of a cGMP Operation for Manufacturing logistics processes relating to Abeona Manufactured Media batch record review and release from start to end of manufacturing activities, in-process sampling / testing, autoclave, and document management ensuring procedural and regulatory compliance throughout the manufacturing process. The Specialist I, Quality Assurance will report to the Associate Manager, Quality Assurance or above and will support manufacturing and quality control as the production area Quality Assurance representative.

We are seeking a highly motivated and independent Scientist to join our rapidly growing Cell Therapy Team. In this role, you will contribute to advancing innovative Cell Therapy products by designing and conducting laboratory experiments, developing methodology, and generating and interpreting scientific data in a highly collaborative environment.Expertise inin vitro and in vivo studies and T cell biology is critical for this role. To be successful in this role, you must be well-organized and keep an excellent written record of your work. You will be based in Gaithersburg, MD and report to the Associate Director, TCR-T Cell Therapy.

We are seeking a highly motivated and detail-oriented individual with a strong background in cell process development and/or manufacturing. The Manufacturing Associate II will report to the Director of Manufacturing and play a key role in supporting daily GMP manufacturing operations for allogeneic CAR T cell therapies.

Perform environmental monitoring and water sampling within the controlled manufacturing areas and QC Laboratory.

Join Agilent as a Field Service Engineer – Pathology and play a critical role in supporting scientists and healthcare professionals in delivering life-enhancing discoveries. In this dynamic role, you will provide on-site technical support, ensuring the optimal performance of Agilent’s pathology solutions. Your expertise will directly impact laboratories by minimizing downtime, optimizing efficiency, and enhancing customer success.

As a Field Service Engineer for Agilent, you will work at a variety of labs, so having an appetite for continuously learning about new instruments, software and consumables is key. Applying your communication skills, creativity and can-do attitude is essential. The ability to help with solving customer problems and a commitment to deliver the highest levels of customer service is how you will build customer success.

Join Agilent’s innovative manufacturing team and help craft the future of smart, compliant, and efficient production systems. As a Manufacturing Systems Engineer, you’ll chip in to the development and optimization of digital manufacturing solutions, ensuring flawless integration of software, equipment, and processes across regulated environments.

The Laboratory Coordinator, QC Analytical Testing is responsible for day-to-day coordination of laboratory operations to ensure that QC spaces are well-maintained, and compliant with GMP expectations. Key responsibilities include oversight of laboratory cleaning and 5S activities, support for equipment calibration and preventive maintenance (PM), pipette verifications, and sample shipment for external testing. This role will work closely with the Laboratory Manager and QC staff to support smooth laboratory operations and execution of GMP testing.

The Scientist II (Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist II (Chemistry) position, TOC, UV, osmolality, density, titration and pH are commonly employed in the described testing in addition to other key methodologies such as KF, CCIT and HPLC. Test methods employed may be compendial (i.e. USP, EP, JP) or proprietary (client supplied or developed by The Company) and may also assist with method verification / method validation projects as needed.

Provide daily repair and maintenance support for assigned products, including installations; Conduct in-house bench repairs and onsite customer repairs as needed while primarily handling field service calls with limited supervision; Travel within the local region (including day and overnight trips) to support customer needs; Offer technical support via phone to customers and field personnel regarding repairs, maintenance and installations.

The Bright Ceramics Technology group (BCT) is focused on developing, applying, and commercializing a unique technology platform based upon advanced materials. They develop and manufacture cutting-edge components and systems. BCT is currently searching for new grad Mechanical Engineers to join their team. The ideal candidates will be able to perform basic engineering analysis, complete detailed specifications, and be able to build and troubleshoot systems with minimal supervision. Working with interdisciplinary teams, the ME will apply their knowledge of mechanical design and materials properties to invent, fabricate, and test complex components and systems that are benchmarks of elegant and effective design. Successful applicants will be proficient in mechanical design and analysis, prototyping, a wide range of manufacturing processes, electro-mechanical systems, 3D CAD, and system fabrication.

Analysis of allergenic extracts by Elisa, RID and IEF. Analysis of preservatives phenol and glycerin by HPLC. Wet chemistry analysis specific gravity, identifications, USP and EP compendia and WFI analysis. Operates laboratory instrumentation as FTIR, GC, HPLC and others

The Quality Analyst in the STERIS Applied Sterilization Technologies (AST) Whippany, New Jersey location is responsible for assisting in administration of the quality management system to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Analyst leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

As the Analytical Chemist at Sterling, you will be accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of active pharmaceutical ingredients development or pharmaceutical manufacturing. Testing performed directly supports manufacturing through the release of raw materials, intermediates and API’s; as well as in-process controls, equipment cleaning verification, reference standard qualification, and stability program. The Analytical Chemist will develop the ability to efficiently organize the routine work with minimum supervision and to properly evaluate and interpret generated data working.

Are you a passionate electrical engineer with a desire to innovate and shape the future of healthcare? Join our forward-thinking medical device team in our Surgical Technologies business unit, working specifically on developing our Next Generation Neptune portfolio, where your work will directly impact patient outcomes. As a key contributor, you will independently design and develop advanced electrical components and sub-systems for groundbreaking medical devices, using cutting-edge techniques in circuit design, testing, and problem-solving.

The Project Engineer is responsible for the strategic oversight and hands-on management of building systems, infrastructure projects, and utility operations across the organization. This role ensures optimal performance, safety, and compliance of all facilities-related functions, including HVAC, electrical, plumbing, and environmental systems. The Engineer will lead cross-functional initiatives, manage capital projects, and serve as a technical expert in building operations, cleanroom design, and sustainability efforts. The ideal candidate operates independently and proactively, driving continuous improvement and operational excellence.

We are seeking a Facilities Engineer with experience in the management, execution, and day-to-day support of building and plant operations, including labs, manufacturing plants, utilities, equipment, and systems. The ideal candidate will perform routine inspections, maintain documented records, and be on-call for emergencies, ensuring compliance with regulatory requirements and GMPs. Effective communication and collaboration with various departments are essential to meet the facility’s needs and quickly resolve any issues.

We are seeking a skilled Research Associate/Senior Research Associate with experience in utilizing display technologies (yeast/phage) in protein engineering, directed evolution, or binder discovery. This is a laboratory-based role that will be supporting protein engineering efforts in discovering novel binders and novel protein leads/scaffolds. The position will join a growing protein engineering team in an innovative organization and reports to the Director of Protein Engineering. The ideal candidate will be a quick learner with a broad experience set with direct expertise in a display technology and/or an adjacent field including but not limited to high throughput molecular biology, antibody/binder discovery, and protein engineering. Industry experience in biologics drug development is required.

Join Takeda as an Engineer I where you will provide process support to the Fractionation manufacturing group by solving technical issues within the Social Circle Fractionation manufacturing facility. You will assist your quality and manufacturing partners in maintaining process compliance, aiding in the implementation of yield and process improvements, and supporting process validation activities. As part of the Fractionation Manufacturing Sciences team, you will report to the Associate Director of Manufacturing Sciences, Fractionation.

Interact with cross functional team members to plan product development activities in support of project requirements and customer needs. Participate in all activities impacting customer requirements including DFMEA, Design Reviews, and Design for Manufacturing Reviews. Take hands on personally committed approach to the Quality feedback loop including resolving customer complaints and plant issues plus line concerns. Participate in development of PFMEA. Responsible for development of Control Plans/Inspection Plans, First Article Inspection and Capability Study planning and acceptance for new or revised tooling, PPAP or other customer required documentation. Create, and Safe Launch plans to help ensure that all production risks are addressed throughout the Project lifecycle. Support all activities relating to the refinement/improvement and creation of process from a quality perspective. Management of internal and external suppliers from a quality perspective. Perform failure analysis using 8D format to clearly define the problems, scope, root cause and corrective actions. Interface with supplier quality engineering as needed to coordinate actions related to supplier process design, inspection and non-conforming materials. Travel as required to ensure project success. This position will have global responsibilities requiring flexible working. Employee must perform his/her job within acceptable safety, environmental, quality, productivity and performance standards as outlined in local and global policies and handbooks. Transmission of customer specific requirements and Quality Manuals into the Project/Product. Risk estimation and mitigation through Project lifecycle using clearly defined and constantly improved measurables including escalation as required.

Work with a cutting-edge genomics workflow to provide high-quality data with rapid turnaround times in a clinical laboratory. Perform routine testing, quality control, calibration, maintenance and proficiency testing in accordance with current laboratory procedures. Perform complex molecular-based procedures with a high degree of quality and in accordance with established protocols. Perform nucleic acid extraction and DNA/RNA quantification and qualification using robotics and automated liquid handlers. Sterilizing laboratory equipment and workspaces as assigned. Entering clinical patient data into the Laboratory Information Management system. Obtain 12 continuing education hours in the field of oncology or molecular biology. Maintain competency to perform all assigned molecular biology protocols in accordance with CAP, CLIA, NYSDOH regulations.

The Microbiologist II is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. The Microbiologist I is also responsible for performing all the microbiological testing related to raw materials, utilities, and in-process product testing. Other responsibilities include data entry, data review, ensuring calibration of equipment, maintaining inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order.

As a Formulation Technician II, you will play a vital role in producing sterile injectables and working on moderate-scale problems that require analysis and critical thinking. You will follow written and verbal instructions to ensure that pharmaceutical products are manufactured in accordance with industry guidelines and regulations.

Provides routine analyses in a biochemistry environment within defined procedures and practices. Performs analytical methods for moderately sophisticated testing on samples, stability, and production intermediates to support process development and/or manufacturing operations. May research and implement new methods and technologies to improve operations. Makes detailed observations and reviews, documents, and communicates test results.

A successful person will perform Environmental Monitoring tasks in support of Steriles production within classified areas. The individual is encouraged to follow the 4i Values that are held in high regards by the company when completing their work. The four values are integrity, innovation, intensity, and involvement. The job function includes aseptic technique which requires the individual to gain knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured.

Perform analyses in a chemistry environment within defined procedures and practices. Perform analytical methods for moderately to complex testing on a variety of cleaning, in process, stability, and release samples. Support internal manufacturing operations. Make detailed observations and review, documents and communicate test results; recommend solutions.

The Lab Technician performs chemical analysis and testing on chemical raw materials and in-process/finished batches according to methods and specifications as defined by the customer. He/she assists with compiling, analyzing and interpretation of results as well as maintaining the flow of samples and paperwork through the laboratory. The Lab Technician maintains laboratory equipment and instrumentation to ensure ideal usage and has a strong attention to detail. The Lab Technician is able to effectively correspond with internal customers, has excellent organizational skills, able to perform physically demanding work such as moving and lifting equipment and capable of standing for long periods of time.

We are seeking a motivated individual to join our team and expand our bioanalytical department. Using state-of-the-art technologies and workflows, this Research Associate would work with the Protein Analytics team to ensure project-specific deliverables are met across a diverse panel of discovery campaigns and contract services. The role would involve wet lab experimental design, execution, and data analysis for multiple custom antibody development projects incorporating various biologics assay formats.

The Laboratory Application Scientist ensures that all laboratory systems composed of equipment, instruments and computerized systems are properly maintained, qualified, calibrated and secured to be properly used by the laboratory users to ensure a high level of confidence with product results. Provide access management for each computer system, while ensuring data handling and data integrity meet internal SOP and FDA requirements. This position is partnered with the laboratory system owners and the IT group. Ensuring all laboratory systems are properly used in chemistry and microbiology laboratories and assisting laboratory staff with technical issues and training. Provides recommendations on efficiency, new technology and best practices in the QC laboratories.

Vantage MedTech is seeking a Design Quality Engineer to serve as the cornerstone of Quality Assurance in cutting-edge design projects, ensuring they meet the highest standards of excellence and compliance. This role is responsible for maintaining alignment with the Vantage MedTech Quality Management System and design control processes, acting as the QA representative on assigned projects. This individual will enhance the capabilities of the design engineering team by overseeing the maintenance and compliance of the Design History File (DHF), Device Master Record (DMR), and document control processes, while upholding compliance assurance for external partners.

The R&D Assistant will work with technical product development on key projects for the R&D team.

We are seeking an experienced and motivated Associate Scientist to join the Bioassay team as a part of our Therapeutic Proteins Department. Our group’s focus is to develop assays to interrogate regulation of molecular function and signaling which contributes to the therapeutic mechanism of action and we play an integral role in discovery and characterization of therapeutic molecules across diverse disease areas. You will develop cell-based functional assays to identify and characterize therapeutic antibodies. We hope you are excited to work collaboratively across functions to meet project achievements, with the goal to deliver therapies that transform the lives of patients.

We are currently looking to fill a Medical Device Quality Engineer position. This position will provide Quality Assurance oversight and ensure compliance in the support of combination device development life cycles.

As a Clinical Research Associate (CRA), you will be responsible for the support and coordination of the logistical aspects of clinical trial management, site management, data review & cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs. You’ll act as a pivotal point of contact for the clinical trial team and assist with the coordination of activities associated with the start-up, conduct, and close-out of clinical trials and other duties as assigned.

Our Manufacturing Engineer focuses on introducing and establishing new Manufacturing Processes plus Process Maintenance and Continuous Improvement for existing Manufacturing Processes. Additional areas of focus may include: setup reduction, operator training, tool design or selection, performance metrics, and drafting development plans. Other daily responsibilities will include: procedure generation, participation in production readiness activities for new clients and designing continuous improvement plans for current production jobs. As improvements are identified, it will very likely be the responsibility of this individual to document, implement, train and re-qualify any changes.

The Safety Scientist within Global Patient Safety Science is an individual contributor who provides safety science and pharmacovigilance support to all products across the RevMed portfolio, which includes early and late phase development activities. The individual will be responsible for supporting clinical studies, review of clinical trial protocols, supporting updates to IBs, ICFs, and authoring of DSURs. Additional safety related activities will involve medical review of individual case safety reports (ICSRs), safety surveillance of assigned products and active member of cross-functional teams.

We are looking for an experienced Senior Research Associate to help the Discovery Sciences team accelerate our search for new oncology therapeutics. The successful candidate will join a high-performing team of experts in the use of biochemical and biophysical screening techniques to drive the efficient identification and rapid development of clinically impactful drugs against frontier targets in oncology. Working from the bench, they will apply their biochemical and biophysical expertise. The candidate will support Discovery Science efforts to enhance how we discover inhibitors of established and new drug target proteins, as well as contribute to our mission of providing high-quality experimental data for existing programs.

The Analytical Development Research Associate will contribute to analytical method development, implementation, and pre-qualification of methods focused on Rion’s exosome technology. This role will work closely with Rion Quality Control to execute method transfers and support continuous improvement. As such, the candidate will possess the technical skills required to conduct experiments and assays in a wet lab environment involving techniques such as mammalian cell culture, ELISA, RT-qPCR, HPLC and colorimetric/fluorometric-based assays. The Analytical Development Research Associate will be responsible for the execution of experiments, as well as data interpretation and final reporting. The position affords the opportunity to serve as a key member of Rion’s scientific team and contribute to the advancement of exosome therapeutics. The Analytical Development Research Associate will work closely with the Analytical Development Scientists and support the efforts of Quality Control/Process Development. As such, the successful candidate will work in an upbeat, highly collaborative and dynamic environment. Additional responsibilities associated with this position will involve assisting in day-to-day laboratory operations such as inventory management, procurement, and general laboratory and equipment maintenance.

The Clinical Trial Associate supports the Clinical Trials team(s) in the overall management and administration of trials, including planning, execution, and closeout of one or more clinical trials in a fast-paced environment. The primary responsibility is to manage administrative tasks on behalf of the team.

This is a 12 hour, rotating position in a large scale cGMP biologics facility. The Sr. Manufacturing Technician will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Serán seeks to hire a Scientist/Engineer to join the Drug Product Development group and contribute as part of an interdisciplinary team to develop and scale-up pharmaceutical manufacturing processes. The role requires strong hands-on laboratory skills and the ability to apply fundamental scientific principles to solve problems. Strengths in data collection, analysis, proactive communication, and continuous learning by textbooks, journals, and training will enable the successful candidate to thrive. The ideal candidate would enjoy a work environment that is both science-focused and adaptable to meet rapidly changing project needs. Preference will be given to candidates with higher experience levels.

We are looking for an Electro-mechanical Quality Test Technician for our Motor Control Center (MCC) team on 2nd shift. This position will be based in Wendell, NC. The Electro-mechanical Quality Test technician is responsible for performing final test and inspection duties on Low and Medium Voltage Electrical Distribution Equipment, such as Switchgears, Switchboards and Breakers.

In your activities you will execute the build of large-scale automated equipment in Walpole Formulation. You will assist in meeting product demand requirements: manufacturing product, allocating bill of materials and routings. You will assist in calibration and maintenance of lab equipment, and lab duties as required. You will work within a regulated laboratory environment: knowledge of and compliance with ISO, GMP, QSR. You will work with laboratory software: knowledge of Microsoft Office, basic understanding of SAP. You will demonstrate a basic knowledge of professional principles and skills. You will use fundamental concepts, practices, and procedures of the particular area of specialization. You will assist in fostering the team environment. Your contacts will be primarily with immediate manager and others in the group. This position includes the handling of all types of materials, including hazardous and DEA (Drug Enforcement Agency) controlled materials.

Varian, a Siemens Healthineers company is seeking a dedicated and detail-oriented Product Quality Engineer to join our team in Palo Alto, California. In this position, you will play an instrumental role in engaging with our local and global partners, driving various transformation initiatives and providing daily support to our manufacturing operations.

The Associate QA Specialist - Quality Events position is responsible for supporting and maintaining the GMP-compliant quality systems related to deviations and CAPAs (Corrective Action & Preventative Action). This role provides quality oversight of quality event lifecycle management, ensures adherence to internal procedures and regulatory requirements, and interfaces directly with internal teams, external clients, and regulatory bodies. This position plays a key role in maintaining site compliance and driving continuous improvement across operations.

At BioLegend (a Revvity, Inc. company) we develop novel, cutting edge products and offer custom services to help with scientific innovation and discovery. We are currently looking for a talented, detail oriented person to join our growing Product Development team. The potential candidate will assist with development of new products for cell analysis such as antibodies, multi-color panels, and reagents for analysis of cell metabolism and cell imaging. The successful candidate must be a self-motivated, team player, able to communicate effectively with a multi-disciplinary team and must possess excellent organization skills.

The Microbiology - Environmental Monitoring Technician supports microbiology and manufacturing activities at the NJ5 site by (1) performing Environmental Monitoring (EM) as per sampling schedules (2) detecting, quantifying, identifying, and aiding in investigations for possible contaminants that may impact the quality of product during different stages of the manufacturing process.

The primary function of a QC Chemist is to perform qualitative and quantitative chemical and physical analysis in support of raw materials, in-process samples, components, and finished drug products testing.

The Clinical Supply Center Bioprocess Technician is an integral member of the Clinical Supply Center (CSC) team in South San Francisco (SSF). The SSF CSC is a state-of-the-art large molecule drug substance facility which supports GMP production for phase 1, 2 and early phase 3 clinical trials. The CSC employs a ballroom design, utilizing single-use technology, new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility. We are looking for individuals to support this facility who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual. Ideal candidates would have experience in a broad range of functional roles in support of biopharmaceutical production.

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production. Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business. Area of work involves manufacturing and business processes with interaction between production, cross-departmental engineering groups, and other cross-functional teams (such as Regulatory, Quality, R&D, Supply Chain, IT, etc.) in executing and coordinating business operations systems projects and activities. Essential job functions include creating and executing an integrated cross-functional project plan.

This Quality Operations (OQ) position will support the Groton, CT PharmSci Small Molecules QO department by assisting in quality operations activities related to the manufacture and disposition of GMP clinical Drug Product. As an Associate Operations Quality colleague, the successful candidate will have quality touchpoints prior to the start of drug product manufacturing through disposition of final drug products for clinical use. Paramount to this role will be acting as a quality point of contact for supporting investigations and ensuring compliance with regulatory and internal standards.

As an Automation Engineer your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

The Associate Scientist will play an integral role in growing the operations and customer base by supporting the analysis of various samples and performing studies/assays independently while delivering exceptional quality with a high attention-to-detail and ensuring client expectations are met.

We are seeking a highly motivated GMP QC Analyst I/ II to join our Cell & Gene Therapy (CGT) Quality Control team. The QC Analyst I/ II will be responsible for executing routine laboratory testing under cGMP conditions to support multiple client projects in various phases of development. This role is suitable for candidates seeking to gain hands-on experience in a dynamic, client-focused, cross-functional CGT laboratory. The ideal candidate will have a strong foundation in biological sciences and laboratory techniques, along with a commitment to quality and regulatory compliance.

Provides assistance to internal clients and is accountable for working independently with minimal supervision. The position requires strong communication skills both verbal and written plus technical skills to accomplish job responsibilities.

Provides assistance to internal clients and is accountable for working independently with minimal supervision. The position requires strong communication skills both verbal and written plus technical skills to accomplish job responsibilities.

Are you intrigued by the science of the human body? Curious about state-of-the-art laboratory instrumentation? Looking to join a Fortune 500 company leading the world in providing diagnostic information services? Quest Diagnostics is now recruiting for technologist positions ranging from entry level to experienced, with a wide range of benefits and training!

The purpose of this role is to provide engineering support to Phlow’s Manufacturing Science and Technology (MS&T) group. This is an exciting opportunity for recent graduates or individuals with process engineering experience to independently design, install, and operate continuous and batch processing equipment under the direction of a Principal Scientist or other team member. The candidate will provide engineering support to the MS&T group including equipment selection and design, heat and mass transfer calculations, and scale-up modelling. The candidate will support execution Phlow’s internal API development projects as well as the CDMO business to ensure business objectives are met. The candidate will ensure excellence of our process development and technical transfer to Phlow’s partners or customers. The candidate will personify Phlow’s shared values and culture, both internally and externally. The candidate will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.

We seek an enthusiastic and curious scientist interested in participating in all aspects of the hit-to-lead drug discovery process. The opening is at our new state-of-the-art facility in Canton, MA. The successful candidate will engage in the Immuno Oncology research areas of the company and will work with a successful team of international senior scientists located in the USA and EU. The ideal candidate will have great communication skills, excellent technical skills, exemplary attention to detail, and a passion for learning. This position will have the opportunity to make significant scientific contributions to numerous drug discovery projects.

The Quality Control Chemist performs analytical testing on raw materials, intermediates, and finished peptide products using a range of laboratory instruments to ensure compliance with quality standards and GMP guidelines. This role prepares samples, calibrates equipment, documents results, and identifies potential quality issues, supporting the development of corrective actions as needed. The chemist also contributes to SOP development and maintains a clean, compliant laboratory environment. This role contributes directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers.

Proclinical is working alongside a pharamceutical company seeking a Staff Scientist to join the team. The Staff Scientist, DMB is primarily responsible for DMPK support of discovery and/or development projects regarding in vivo pharmacokinetics studies. The successful candidate will involve preparing doses for, scheduling, and coordinating in vivo pharmacokinetics studies as well as generic lab functions with the opportunity for cross training on in vitro assay support.

We're seeking a Manufacturing Engineer II with Metrology Focus to join our Manufacturing Operations team. This is an important role that safeguards product integrity and regulatory compliance through advanced metrology systems and precision measurement protocols that directly impact patient safety and market access. We are seeking a Manufacturing Engineer II with Metrology Focus to join our Operations Engineering team at ProMed Molded Products. You'll design and implement metrology systems that ensure dimensional accuracy across manufacturing processes while developing quality assurance procedures that detect non-conformances before product release. Your expertise will establish measurement uncertainty analysis and gauge repeatability studies, validating system capability for reliable quality data. You'll create process validation protocols and documentation systems supporting regulatory submissions, while designing manufacturing work instructions that ensure consistent execution and reduce operator variability in our medical device manufacturing environment. We're only considering candidates from The Minneapolis Metro area. No relocation assistance is available for this role.

We are hiring an experienced Commissioning Engineer to provide comprehensive Commissioning Services for Facilities Capital Projects. In this role, you will be responsible for ensuring the successful commissioning of systems and equipment, from design through to post-handover. You will oversee and coordinate all commissioning activities to ensure systems are properly tested, validated, and ready for operational use, in line with project specifications and industry standards.

Psomagen Inc. is a leading multi-omics service provider specialized in NGS, Sanger, single cell sequencing services to support life science research and industry field in North America. The NGS clinical laboratory technologist will perform day-to-day NGS experiments including sample preparation, library preparation, QC procedure as well as various NGS instrument operations.

The Senior Technical Associate, Production Molecular Biology must comprehend and perform scheduled routine bulk formulation production tasks according to established procedures in compliance with applicable regulations, including troubleshooting with assistance.

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Quality Assurance Specialists are leading service providers to our clients providing GMP support. The individual will coordinate validation activities with the client and meet timelines.

As we continue to thrive together QuidelOrtho is seeking a Clinical Trials Associate to support in all clinical team activities for start-up, oversight, and study closure to include coordinating the preparation and assembly of clinical trial supplies and materials for distribution to clinical sites with minimal/moderate supervision. Maintain related tracking information of all clinical materials, shipments, and inventory. Assist the Data Management team in tracking and management of Case Report Forms (CRFs) and Laboratory submission Forms (LSFs). Assist in maintaining files and tracking of all written and electronic documentation for all study records and site interactions in the Trial Master File (TMF). Communicate with sites regarding query resolution to ensure compliance with specified protocols and accuracy of submitted data. Participate in data entry, data auditing, clinical site queries and overall clinical data flow from multiple clinical sites in a timely and professional manner. Coordinate in-house specimen procurement studies. Willingness and ability to learn, understand and apply regulatory guidelines and Good Clinical Practices (GCP’s) applicable to IVD and Medical Devices for conducting clinical field trials, CLIA Waiver and 510(k) submission studies. Be familiar with GCP, FDA regulations and relevant Standard Operating Procedures for clinical research. Develop skill and knowledge with regulatory procedures and become familiar with Quidel product development procedures. Interact with study coordinators and in-house study participants.

As we continue to grow, we are seeking an Engineer II to join our R&D Field Triage group. This individual will assist in conducting technically challenging investigations to address on-market product quality issues and recommend solutions. This role involves working in a highly collaborative team setting to provide R&D investigational support including design, execution and documentation of experiments to systematically identify failure mode/s and establish root cause/s with clinical laboratory and transfusion medicine products. This position is on-site at our Rochester, NY facility.

Our QC Laboratory Technician plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include performing basic laboratory support functions related to the management of laboratory samples, materials, and testing supplies. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

The Engineer - Automation/Process Serialization is accountable for the direct support throughout the design, build, site integration and verification for the new Packaging lines delivered in all Lilly Sites following GSP (Global Serialization Program) processes and procedures. Your role will involve collaborating closely with the Engineering and IT teams (Global and site).

The Cell Processing Specialist is responsible for cell washing operations and verifying cell processing intermediate processing days of patient derived clinical and commercial cellular immunotherapy products. The CPS I will also be responsible for the formulation and verification of all media lots. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.

The Maintenance Technician is responsible for performing corrective and preventative maintenance and support services for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. Responsible for reliable, efficient, and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area.

The HSE Technician will be responsible for supporting all HSE compliance aspects at our new state-of-the-art Isotope Manufacturing site. You will help ensure Health, Safety and Environmental activities are managed according to applicable laws and Novartis HSE Management System requirements and assist in the continuous improvement of applicable HSE Management Systems while helping to spread our safety and environmental culture by proactively engaging associates and enhancing awareness.

The Life Science Lab Technician (Technical Manufacturing) performs a wide variety of routine production tasks in Technical Manufacturing and must be capable of producing large-scale components for MP Bio life science products. The Lab Technician must be capable of following work instructions and finish assigned tasks on time. The ideal candidate will have a strong background in Chemistry, Biochemistry, and Biology, attention to detail, time management skills, and the ability to work effectively in a team environment.

Executes routine testing per NAMSA SOPs, with appropriate data analysis (cytotoxicity and hemocompatibility). Strictly adheres to GLP guidelines (good documentation, labeling and expiration of materials, participation in audits). Performs maintenance of cell lines through propagation, cell concentration and viability determination, and creation of plates used for standard testing. Performs the extraction process on prepared samples in accordance to ISO, USP and/or JMHLW regulations as directed by study protocol for biocompatibility assays. Communicates with external clients in regards to particulate observations or article abnormality. Routinely communicates with Study Directors and Quality Assurance about issues, results, or audits. Operates, cleans and maintains incubators, autoclaves, hoods, and other equipment routinely utilized. Performs preparation of media/reagents, maintains reagents and/or test article as required for testing, and maintains lab supplies/inventory. Performs data entry, routine calculations, analysis and interpretation of results, and routes all positive results or unusual testing occurrences to Management and/or the Study Director. Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management or Study Directors as required. May assist Associates with performing routine test article/product preparation according to work instructions. May communicate test schedule updates to NAMSA Associates or management as needed. Maintains ancillary records (logbooks, worksheets). May be required to perform personal gowning, environmental testing, and submitting organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing. Adheres to established company processes. May provide administrative support. May prepare and maintain sterile glassware for the In-vitro lab and sample preparation process. Processes glassware through washer, autoclave and depyrogenation oven as needed. Completes chain of custody documentation for test article tracking. Responsible for daily monitoring of laboratory equipment, being on-call and responding to continuous monitoring alarms. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. May assist in ordering and/or stocking supplies subject to approval. May assist trainers or may become a certified tra

Assists in analyzing specimens and maintains equipment in good operating condition.

Under the direct supervision of licensed personnel, or within a training environment, the Laboratory Technician will assist with responsibilities associated with processing specimens for clinical testing and will provide general support for the laboratory following established policies and procedures. This is the entry level for the Laboratory Technician job category. The employee works in a learning capacity while performing a range of laboratory technician assignments under close supervision.

The Quality Assurance (QA) Specialist will work with Neuralink's teams to ensure that the appropriate governing body regulations are followed. This includes, but is not limited to, adherence to ISO standards, Good Laboratory Practices (GLP), clinical guidelines, manufacturing protocols, and quality control practices.

We are seeking a skilled Test Technician to join our team. The ideal candidate will be responsible for testing and troubleshooting medical robotic systems while adhering to Good Manufacturing Practices (GMP). The successful candidate will have a strong understanding of robotic hardware, sensors, motors, PLC’s, relays, circuit boards, computers, cabling and experience with and testing, excellent troubleshooting skills, and GMP experience.

Apply product design, materials and parts, fabrication process, tooling and production equipment, capabilities, assembly methods, and quality control standards knowledge to develop, evaluate, and improve Nortech’s product design, materials and parts, fabrication processes, fixtures, tooling and production equipment capabilities, assembly methods, and quality control standards. Interact with operations, manufacturing, finance and other internal subject matter experts to define, design, test, implement, and support high-quality, efficient, and cost-effective product tooling and manufacturing processes. Apply Lean, Six Sigma, and FOCUS methodologies to assist with analyzing and planning workforce utilization, space requirements, workflow, and designing equipment layout and workspace for maximum quality and efficiency. Coordinate with Quality and work to establish process controls on new products. Review and estimate production times, staffing requirements, and related costs to inform management decisions. Communicate manufacturing capabilities, production schedules, or other information to facilitate production processes. Participate in vendor discussions, evaluate and recommend equipment product specifications and arrange equipment, material purchase, and parts in partnership with internal subject matter experts.

This position has primary responsibility to support the manufacturing processes for the given area. This position requires strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This is a cleanroom/sterile environment that will require regular gowning, and strict to all procedures in order to ensure the safety of our products for our patients. Prior experience in cleanroom, laboratory, or other sterile environments is a plus, and prior GMP experience is a plus as well.

This position works under limited supervision and is responsible for assisting in the Research and Development activities of probiotic powder formulations for encapsulation, powder filling and tableting applications. This position works directly with Product Development and Sales functions.

Execute routine quality control testing activities as assigned by management. Support CAPA’s, change controls, investigations, and deviations. Participate in the development and validation of analytical methods for Analytical Development group. Participate in testing, project support, data review, ordering of laboratory supplies, and general upkeep of the laboratory.

The Cell Therapy Production Associate, Oncology plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.

The Quality Engineer I supports the ongoing quality of Orchid's legacy products & processes and works cross-functionally to sustain the business.

This is an entry level position. The Associate will perform all activities involved in the aseptic processing of a living product (Dermagraft), under the direct supervision of the Dermagraft Team Leader/Dermagraft Supervisor/Manager. The Dermagraft Associate will support the Dermagraft Manufacturing department by performing the tasks that will assure the safe and timely processing of Dermagraft, working in both a ISO 7 and ISO 8 cleanrooms.

PBL has immediate openings for a Research Assistant I/II/III in the In Vitro Services Department. The In Vitro Research Assistant is a laboratory level job focusing on the development, optimization, and execution of a variety in vitro (i.e., cell-based and noncell-based) test methods. Successful candidates will be familiar with laboratory procedures including the use of analytical balances, calculating, and preparing dilutions, pipetting, measuring pH, documenting study activities, and analyzing/interpreting data. The In Vitro Research Assistant is expected to perform under minimal supervision. Research Assistants may also contribute to general laboratory operations including equipment maintenance and maintaining a clean and organized laboratory environment.

Join us at PCI as a Quality Associate I – Operations, where you’ll be on the front lines of GMP production—supporting real-time quality oversight, solving problems as they arise, and ensuring that every product meets the highest standards of safety, efficacy, and compliance. This is an ideal role for early-career professionals passionate about science, quality, and continuous improvement. You'll receive hands-on training, mentorship, and exposure to industry best practices while working in a fast-paced, collaborative environment.

PCI is seeking a motivated and detail-oriented Process Engineer I to provide technical leadership in new product launches and continuous improvement initiatives. The ideal candidate will focus on mitigating packaging issues, optimizing production processes, and supporting operational efficiency. This role will involve providing technical and operational support to production, maintenance, and support teams, particularly in the areas of process improvement, equipment modification, optimization, safety, and quality improvement. The Process Engineer I will utilize lean and six sigma techniques and demonstrate excellent organizational and leadership skills in managing projects, equipment needs, staffing projections, and line layout.

As a Manufacturing Engineer you will be overseeing and optimizing the production process, from raw materials to finished products, to ensure efficiency and quality. The type of material is expected to be electronic, electro-mechanical, and mechanical. This position will require frequent coordination with Planning & Production Control, Engineers, and Operations Leads to ensure that material will be available when needed and that proper documentation is in place for floor operations.

Leidos’ Defense Systems RF Systems Portfolio is seeking a Research Scientist to join our team of engineers, analysts, and scientists supporting advance radar system analysis in a high-fidelity modeling and simulation environment. Our expertise is setup, test, and evaluation of radar system performance using modeling and simulation of modern air defense systems.

This is an exciting opportunity to use your experience to advance the Air Force Research Labs (AFRL) Rapid Technology Development and Demonstrations (RTD2) program. In support of the RTD2 program, your position as a Mechanical Engineer will be to support AFRL programs mature new and emerging technologies and supporting Leidos internal research and development. The position objectives are to provide technical and operational support of new and evolving sensor systems and sensor technologies, provide support for ground and flight demonstrations and tests, and to perform sensor system integration into laboratories, aircraft, and other vehicles/platforms as necessary.

Leidos is seeking a talented Cable Manufacturing Engineer to join a diverse team to create unique solutions for complex problems. With offices across the United States engaging in the defense, space, cyber and commercial fields, Leidos provides responsive, cost-effective engineering, scientific and IT solutions. Candidate will develop, document, and execute manufacturing processes and procedures for cable assemblies and electromechanical products. Use of a Manufacturing Execution System (MES) will be required to create work instructions and develop build strategies. Candidate will support production of cable assemblies and electromechanical assemblies and systems. Applicant will work with a multi-disciplinary team to develop a wide variety of hardware, and work with the latest automated technology used in assembly and test equipment.

The Associate Chemist is responsible for analytical, environmental and physical testing. He or she also performs testing on raw materials and compounded products. This chemist will also participate in the development and formulation of new products under the direction of a Chemist or Senior Chemist. The Associate Chemist may provide any necessary technical support to various other departments. In addition, he or she is responsible for any other task the Chief Technology Officer deems necessary.

The Associate Data Engineer will be responsible for supporting the organization’s data engineering activities, enterprise reporting through Microsoft Power BI, and help maintain IT/OT and data analytics applications. The ideal candidate will have experience in performing ELT/ETL processes using various data engineering tools, have a solid foundation of data warehousing concepts, and know how to build reports/dashboards using Microsoft Power BI. This is a hybrid-based position requiring employee presence, on site 50-100%.

Performs all QC Lab activities, including but not limited to: all Standard Work Process (SWP), Management Systems, and analytical responsibilities.

The primary purpose of the Environmental Health & Safety (EHS) Supervisor is to lead the EHS function at a pharmaceutical tableting facility. Proper execution of this role will help ensure the site is a safe workplace and that it performs in a manner that meets or exceeds the company EHS strategy and expectations. The EHS Supervisor will also champion and collaborate on projects that support the goals and objectives of the site or the Company.

We are seeking a highly-motivated In Vivo Pharmacology Senior Research Associate who thrives in a fast-paced and creative environment to push the capabilities of our multiplexed in vivo drug discovery platform. Together with senior researchers, you will play a critical role in executing in vivo studies to support internal research projects. This is a hands-on role and you should have extensive experience in multiple aspects of in vivo pharmacology including dosing, necropsy, perfusion, tissue collection and sample processing, among others. The ideal candidate must be able to work effectively both in a collaborative setting and independently.

The Product Development Associate I is involved in assisting with the planning, conducting and analyzing experiments leading to validation of diagnostic tests in the field of oncology. The PD Associate works in a team and needs to communicate relevant information to professional colleagues and to participate constructively in discussions that will impact the performance of the final product.

Meadowhawk Biolabs is seeking a highly motivated and dynamic Research Associate II to work within the Discovery Bioanalytical Team at our Marlborough, MA location to perform LC-MS/MS assays in a fast-paced team environment. The ideal candidate is driven, hardworking, willing to learn, dedicated, and passionate about science. Given that we are a newly launched Contract Research Organization (CRO) founded by an experienced team of industry veterans, this ground floor position offers unique opportunities for the successful candidate to contribute meaningfully to the creation and development of our services, expand their knowledge base by participation in multidisciplinary teams, and advance their career in capabilities and responsibilities.

The Manufacturing Engineer II is responsible for providing daily support of multiple product families with specific regard to product quality, product cost, process development and process improvements, safety, and project management activities in procurement of new forming, grinding, laser drilling machineries, and development of manufacturing equipment validation documentations. Duties include managing and/or participating in cross functional teams to accomplish project specific goals. This position is in North Haven, CT. It is a full-time onsite position.

Medtronic pioneered the field of neuromodulation with groundbreaking innovations, including the first commercially available spinal cord stimulator (SCS) for chronic pain, the first deep brain stimulation (DBS) system for movement disorders, and the first implantable drug pump for targeted medication delivery to the intrathecal space of the spine. More than 40 years later, we continue to push the boundaries of innovation, constantly challenging ourselves to disrupt the markets we created. By advancing science with bold thinking and collaboration, we bring together the right expertise to engineer groundbreaking therapies and technologies that transform patient care.

Medtronic – Milwaukee, WI manufactures spinal implants and Brain/ENT instrument components. As a member of Supplier Quality Engineering, you will be responsible for management of external suppliers to Medtronic, Milwaukee. You will lead oversight of supplied products, ensuring conformance to purchased material requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations.

The Manufacturing Test Engineer I will provide hands-on electrical engineering support for Mevion’s manufacturing operation, focused on proton therapy systems. This entry-level position involves assisting with the development and maintenance of production test setups, improving test documentation, investigating failures, and supporting continuous quality and process improvements across internal and supplier environments.

The Quality Systems Specialist is responsible for the timely and accurate maintenance of vendor qualifications, complaints and adverse event investigations, and oversight of training in support of drug product development and production.

We are seeking a highly motivated and detail-oriented Senior Research Associate to join our Flow Cytometry Core Team. The successful candidate will play a critical role in supporting method development and execution of high-throughput flow cytometry experiments, and tissue-based sample preparation. This role offers the opportunity to contribute directly to cutting-edge discovery and translational research programs through high-quality technical execution and scientific collaboration.

Moog is currently hiring a Systems Engineer in our Space and Defense Group. Come join a leading global supplier of motion control and electronic solutions!

Sterility Assurance – Technical Services/Manufacturing Scientist (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies. Primary objectives include the start-up and compliant manufacturing of gene therapy drug product and drug substance, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management.

This role is a member of the Technical Service Manufacturing Science function within the Drug Product External Manufacturing organization (DPEM). This role is responsible for all technical activities related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards. This role is the process expert for the step(s) of the product(s) and process(es) for each contract manufacturing relationship with focus on Device Assembling and Packaging. This role is a member of the joint process team (JPT) and has direct responsibility for oversight of the day-to-day operations and technical agenda at the CM.

The primary purpose of this position is to perform work which involves conventional engineering practice. Ensures Integer’s internal and external customer expectations are met or exceeded.

The Engineer II, Continuous Improvement will play a crucial role in driving and facilitating process improvement initiatives across the organization. This role involves analyzing current processes, identifying areas for enhancement, and implementing strategies to increase efficiency, reduce waste, and improve overall operational performance. The ideal candidate will have a solid background and understanding in process improvement methodologies, excellent analytical skills, and the ability to lead cross-functional teams. The engineer will initiate and support implementation activities for changes approved within Integra’s change management program. The Continuous Improvement Engineer II will work within cross-functional core teams on the development of new products ensuring on-time transfer of new products to production. This is an individual-contributor position.

This position is for a Sr. Manufacturing Quality Engineer l with hands-on experience and proven success in managing Quality systems. The successful candidate will be responsible for partnering with sterilization and microbiology Subject Matter Experts to assist in root cause investigations related to sterility and microbiological outputs, review and assess the accuracy and sustainability of process requirements as they pertain to sterility assurance and microbiology and drive cross-functional collaboration with quality groups across the organization. This role requires a strong quality mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to eQMS, risk assessment, PFMEAs, process controls, root cause investigations, CAPA, and continuous improvement

The Microbiology Technician I will provide support to the QC Microbiology Laboratory as pertaining to the respective responsibilities. Performs functions such as executing laboratory testing for in-process and finished good products, water, stability studies, and validation studies as well as performs environmental monitoring. This position is responsible for operating in compliance with all applicable procedures and policies

This position is for a Design Quality Engineer l with hands-on experience and proven success in managing Design Quality systems. The successful candidate will be responsible for partnering with sterilization and microbiology Subject Matter Experts to assist in root cause investigations related to sterility and microbiological design outputs, review and assess the accuracy and sustainability of product requirements as they pertain to sterility assurance and microbiology and drive cross-functional collaboration with design quality groups across the organization. This role requires a strong quality mindset, a willingness to learn about sterilization and microbiology, an understanding of medical device quality systems, and a commitment to ensuring product safety and compliance. The ideal candidate should demonstrate proficient experience with quality management concepts including but not limited to eQMS, risk assessment, DFMEA, process controls, root cause investigations, CAPA, and continuous improvement

Set up and execute routine laboratory experiments, perform DNA isolation and associated quality control assays, maintain plasmid library using high throughput techniques, perform tasks using aseptic techniques including working within a biological safety cabinet, and organize large data sets within an Excel spreadsheet.

The Manufacturing Technician II is responsible for manufacturing next-generation sequencing reagents and kits, working both independently and as part of a team in concordance with established procedures and ISO 13485 guidelines. This position reports to the Manufacturing Supervisor and is part of the xGen Manufacturing team located in Boulder, Colorado and will be an on-site role.

The Manufacturing Associate I is responsible for executing and monitoring manufacturing processes on the plant floor. They are also learning and becoming familiar with navigating Inventprise Quality Systems and will provide information to help support the reporting of administrative and compliance related tasks including: nonconformance investigation and report writing, generation and execution of CAPAs, and revision and creation of batch records and standard operating procedures.

We are looking to add a Quality Control Laboratory Associate I is responsible for ensuring that only quality products are released for distribution. It is a QCLAI’s job to ensure that products are tested to meet the applicable government regulations and industry standards, and to maintain GMP environment. The Quality Control Laboratory Associate is also responsible for data entry.

IQVIA is hiring a Clinical Research Associate with on-site monitoring experience in GLP-1/Obesity/Diabetes (Type II) clinical trials. Phase 1 experience is a plus! Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

We are seeking a Laboratory Technical Specialist to join Q2 Solutions, IQVIA’s laboratory business at Valencia, CA We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development. You will lead the production and development of specialized reagents for digital ELISA assays, collaborating cross-functionally to drive product transfer and support diagnostic assay manufacturing. This is a fully on-site position.

The R&D Project Manager I is responsible for managing PMO initiative projects by coordination of cross functional project activities to ensure projects achieve desired outcomes. Under guidance and direction, this role will be responsible for supporting the successful implementation of best practices throughout the project lifecycle.

Pharmaceutical Ingredient (API), intermediates, impurities, starting material and excipients from drug substances and drug products. Analyze organic and inorganic compounds to determine chemical or physical properties, composition, structure, relationships, reactions, using chromatography, spectroscopy, spectrophotometry techniques including HPLC, UPLC, IC, GC, MS, UV, XRPD, DSC, TGA, NMR, and KF. Design and perform method verification and validation. Determine the specificity, linearity, accuracy, precision, forced degradation, robustness of the methods. Collect and analyze data, and maintain data integrity under GMP, GLP, and FDA regulations. Prepare documentation of test procedures and technical reports. Prepare, review, and/or approve methods, protocols, and development reports. Maintain laboratory instruments to ensure proper working order. Apply scientific expertise to troubleshooting, laboratory investigation and problem resolution. Participate in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.

The weekend shift Process Engineer I/II/III/Sr. provides ownership and focus for pharmaceutical processes and technical transfers at Jubilant HollisterStier. This position will engage in and manage projects and multi-disciplinary teams with direct supervision. The process engineer will also contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees.

The QC Microbiologist I/II performs the microbial analysis on allergenic and client components, raw materials, intermediates, and finished products following written procedures, providing the data required to determine raw materials/product disposition.

Testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities includes laboratory support, program testing, reporting of results, execution of protocols. This person is responsible for the aspects of the following programs as directed by management: Environmental Monitoring (Air Viable, Total Air Particulate, Surface Viable); Clean Utility Monitoring (Water Sampling, Bioburden, Conductivity, TOC, Coliform and Nitrates); Compressed Gas Monitoring (Collection, Air Viable, Total Air Particulate, Dragger Tests and specific ID tests); Product Testing (Bioburden, Endotoxin, Host Purity, or Non-Host); Media Release; Laboratory Support. It is the expectation that this position is required to be onsite full time. Addition, this position should be in the laboratory/facility for a minimum of 75% time daily. Second Shift: Sunday - Wednesday [2:00 PM EST - 12:00 AM EST].

The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment.

Join a highly technical analytical team in a dynamic work environment where you will participate in contracted client analytical programs as a member of the Analytical Development (AD) Department. The individual in this position will be responsible for executing experimental protocols and performing data analysis in biopharmaceutical laboratories.

This is an exciting role within an expanding team of process and product development specialists and offers the successful candidate an opportunity to make a significant contribution to the development of new inhalation products. The person hired for the position of pMDI Product and Process Development Scientist will support the development and testing of pMDI pharmaceutical products.

Krystal Biotech, Inc is seeking a highly motivated and dynamic Bioprocess Engineer to support our product manufacturing at our Pittsburgh GMP facility. This role is critical to our make a meaningful difference in the lives of underserved patient populations having rare diseases. Quality, safety and on-time delivery is a must to be successful in this role! The ideal candidate will have foundational experience in upstream and/or downstream biologics or gene therapy manufacturing.

Supports production area in tooling design, process improvement, and cost improvement.

As a Research Associate, you will participate on a multi-disciplinary drug discovery team through the design and synthesis of new molecules. The successful candidate will have an excellent track record and a commitment to tackling drug discovery challenges through organic synthesis.

We are seeking a highly motivated, attentive, and self-driven candidate to join our team, Biologics Pivotal Formulation and Process Development, as a Senior Research Associate. Once onboarded, the successful candidate will contribute in developing formulation and drug product processes for innovative molecules. The candidate will have tremendous opportunities for career growth in a fast-paced and resource-rich environment through training and professional relationships. The ideal candidate is expected to be action oriented with high expectations of themselves and others. S/he should have good verbal and written communication interpersonal skills.

Design and implement product line extensions, working closely with the R&D, clinical, and regulatory teams. Champion Design for Manufacturing (DFM) improvements across launched product lines to optimize cost, reliability, and manufacturability. Resolve manufacturing challenges through vendor coordination and iterative design updates. Provide technical support during cadaver labs and customer engagement meetings to validate and refine device performance. Support surgical cases in the operating room, working directly with surgeons to gather real-time feedback and identify clinical opportunities for improvement. Perform product scrap analysis and coordinate remediation strategies to improve yield and performance. Conduct complaint evaluations, identify root causes, and implement corrective actions in collaboration with cross-functional teams. Lead and contribute to Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) in compliance with global regulatory standards. Drive risk analyses to assess and mitigate design and process risks.

The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requiring working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations.

Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day!

The QC Microbiology Technician supports quality control and assurance by assisting the microbiology department with environmental monitoring, water testing, and client specific testing.

The Environmental Health & Safety (EHS) Specialist I or II works with EHS Department to review and interpret regulatory requirements, relating to EHS, and provide cost effective recommendations to the EHS Manager for implementation and compliance. The EHS Specialist I performs a variety of complex tasks and assist in the work of others. The EHS Specialist II performs a variety of complex tasks and may lead and direct the work of others. A fair degree of creativity and latitude is expected with either the level I and/or level II role. This is an on-site position.

The Engineer I - Validation / Engineer II – Validation / Validation Specialist I / Validation Specialist II / Sr. Validation Specialist I position supports Fractionation, Purification, Filling, Utilities and/or capital projects as required. This position is responsible for assigned qualification and validation related activities related to supporting the Clayton NC site.

The Biospecimen Associate I supports the management of patient samples and provides the link between the Clinical Operations and Client Services teams. The Biospecimen Associate I is responsible for receiving, unpacking, processing, and recording samples sent for laboratory testing under the supervision of the Biospecimen Management Supervisor. The Biospecimen Associate I has demonstrated an understanding of laboratory workflow.

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated QA Inspector, QA. In this role, you will be responsible for monitoring in-process product quality for Filling and Inspection and Packaging of parenteral products. The QA Inspector is responsible for performing visual and functional testing of product against statistically based sampling plans. In addition, the QA Inspector performs routine inspection and testing of components in accordance with Standard Procedures and specifications as required by production scheduling. In performing the above duties, the individual is responsible for accurately and clearly documenting test results in accordance with cGMPs. This position participates in rotation for weekend coverage and as needed during the work week.

Are you a quality-focused professional passionate about ensuring excellence in manufacturing and production processes? Join Hologic as a Senior Quality Assurance Engineer and play a critical role in designing, implementing, and maintaining quality assurance protocols that meet internal and external regulatory standards for worldwide distribution. In this role, you’ll collaborate with cross-functional teams, lead quality initiatives, and drive continuous improvement to ensure the delivery of high-quality, innovative products that improve lives globally.

As our Regulatory Affairs Associate, you will be an individual contributor responsible for analysis, evaluation, preparation, and submission of documentation for regulatory approval, ensuring Hyperfine products and procedures comply with US and global regulatory specifications. You will support our Regulatory team across different program areas, and will work on multiple projects concurrently.

As a Chemical Library Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. In this role, you will contribute to the development and expansion of our internal high-throughput screening chemical library, supporting the discovery of new therapeutic entities. This position offers an exciting opportunity to apply your chemistry expertise in a dynamic laboratory environment. The successful candidate will play a key role in a variety of departmental initiatives and laboratory-based tasks, gaining hands-on experience in cutting-edge discovery chemistry projects.

The Field Service Engineer plays a critical role in delivering exceptional on-site technical support for Illumina’s cutting-edge products. This position serves as a key liaison between customers and internal teams, ensuring optimal performance and satisfaction through expert service and support.

As a Quality Engineer I, you’ll be instrumental in upholding the quality and compliance of our in vitro diagnostic products. You’ll collaborate with cross-functional teams to ensure our assays meet regulatory standards, perform reliably, and are safe for clinical use. Your strong organizational and communication skills will help foster a culture of quality and continuous improvement across the organization.

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Manufacturing Specialist is a key technical role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, or within highly regulated industries.

We are seeking a Bioengineer or Senior Bioengineer, Immunology to join the team full time to accelerate the biological development of Hydropore at our Berkeley office. Indee Labs is headquartered in Berkeley, CA and accommodates remote work. This position will be located in Berkeley, CA and occasional work travel may be required.

Hybrid sales and technical position which provides Applications Support and some Sales Support in digital pathology and image analysis for Indica Labs' HALO, HALO Link, and HALO AI platforms in a commercial, educational, or research environment.

Reporting to the Director, Product Quality Complaints, the Product Quality Complaint Associate, QA will play a key role in the complaint process. Specific areas of responsibility include: Ensure accurate and thorough complaint intake information, replacement need, trouble-shooting with complainant, patient follow-ups, product complaint investigations, tracking and trending of complaint data. The position is based in our Bridgewater, NJ HQ (onsite 3 days a week).

Element has an opportunity for a Microbiologist to join our growing team in Fort Wayne, IN. The primary responsibility of the Microbiologist is to support laboratory operations by conducting the relevant microbiological testing.

Element has an opportunity for a Test Technician (Corrosion) to join our rapidly expanding team in Wixom, MI. Primary responsibilities include a variety of routine and non-routine testing assignments to assist the Corrosion Testing department. The technician must insure timely and accurate test results with minimal direct supervision.

The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Detects, participates and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff.

Your primary role as a Research Associate on the Synthesis team at EnPlusOne is to support the enzymatic RNA synthesis platform. You will assist staff scientists in RNA synthesis, reaction screening, data analysis, buffer preparation, QAQC, and inventory. You will work on multiple internal projects and external collaborations. You will be expected to keep a well-documented lab notebook, stay highly organized, use good communication, and collaborate well with our awesome team. Successful candidates are self-starters who are endlessly curious, excited by research, and flexible in a fast-paced, constantly evolving field.

Perform physical, chemical, and instrumental analysis of active pharmaceutical ingredients and finished pharmaceutical products (tablets, capsules, parenterals, devices, aerosols, liquids, creams, and gels). Run the instrumentation independently including, but not limited to, various chromatographic systems, Karl Fischer (Coulometric and Volumetric), UV/Spec, various wet chemistry analyses, HPLC, IC, IR, ICP, AA, TGP, DSC, PDA, auto-titrators, TLC, and dissolution apparatus. Preparing samples for analysis and running some instrumentation with minimum supervision. Set up and validate new analytical or related processes used by the department. Prepare standards and samples for analysis. Execute method transfer protocols. Document work as required for GMP compliance. Perform monthly maintenance of laboratory equipment

Initiate continuous improvement initiatives for Asset management and laboratory Operations and update impacted procedures. Maintain and support best business practices for Asset management such as Share Point Asset management. Work with managers, coordinators, and staff of labs to resolve instrumentation documentation issues. Work with QA and compliance to initiate, investigate, and resolve quality issues. Review QA’s monthly overdue work order list and research instrument service history and use to resolve documentation issues. Review training documents to see which are coming due for their 3-year update. Verify CAR-T data for regulatory submission and make SharePoint updates. Verify regulatory submission needed, and make Share Point updates. Facilitate change control closure and send out notifications to activity owners and approvers. Make status updates to change control SharePoint. Work directly with vendors to resolve instrumentation accuracy and inventory documentation issues. Support inventory accuracy for laboratories in Malvern and Spring House sites. Update Maximo/eCMMS to address inventory inaccuracies, and maintain eCMMS system’s accuracy. Provide process improvement and instruction to decrease turn-around time for bringing instruments into service. Research asset history for resolution of outstanding work orders.

The Upstream development engineer will work primarily with scientists/senior research associates or engineers in the upstream fed-batch culture process development team to design and optimize consistent cell culture processes that produce quality recombinant proteins through laboratory studies. Additionally, as a fundamental component related to cell culture process design and development, the process development team will also ensure that these processes are predicable, scalable, and controlled with multiple size of bioreactors (ambr15, ambr250 and bench-top scale bioreactors). The position is to support tech transfer of developed/locked cell culture processes to pilot team and CMOs.

We are seeking a creative and technically strong immunology-focused discovery scientist to join our Immunobiology team. The ideal candidate will have expertise in T cell engager biologic functional assessment, including tumor killing, cytokine production, T cell exhaustion assays, and multiparameter flow cytometry immune cell analysis. Experience in T cell engager discovery, particularly in evaluating CD3 bispecifics or costimulatory biologics, is preferred. The successful candidate will contribute to the discovery and assessment of novel costimulatory T cell engagers to determine key differentiation design features and supporting mechanisms of action. This includes designing and performing functional assays to prioritize alternative protein designs based on tumor killing potency, cytokine release and immune modulation mechanism of action. Collaboratively design in vivo proof of principle studies to test in vitro-driven hypothesis on molecule prioritization, mechanism of action, lead assessment, and selection of preclinical models to evaluate immune pharmacodynamic and establish in vivo mechanisms of differentiation. They will also work closely with our biotherapeutics and in vivo pharmacology research teams to drive T cell engager platform discoveries to drug development programs. Strong verbal and written communication skills are necessary, as is a proven track record of scientific and project achievements in biopharma. We are looking for a candidate who thrives in a collaborative, team-oriented environment and is eager to leverage the growth opportunities within a matrixed organization. This is an exceptional opportunity for a scientist passionate about T cell engager platform discovery and driven to translate innovative research into novel therapeutics.

The Laboratory Service Technician IV is responsible for the Instrument Services of laboratory equipment and instrumentation, including installation, calibration, maintenance, and repair. This includes both simple (e.g., orbital shakers) and complex (e.g., liquid handling robotics.) instrumentation in the various laboratory environments. These environments may include clinical laboratories, R&D laboratories, and manufacturing and quality control laboratories. The individual in this role will continuously work with other Lab Service Technicians and the laboratory teams to ensure proper instrument function and to troubleshoot any system concerns. The LST may work continuously with other technicians and the laboratory teams to ensure proper instrument function and to troubleshoot any system concerns.

The Continuous Improvement Engineer will be responsible for developing and sustaining performance management systems, lean manufacturing practices, and continuous improvement initiatives across operations, fulfillment, and other departments as needed. This role will focus on optimizing workflow, improving material and information flow, and implementing standardized work at all levels. The Industrial Engineer will play a key role in fostering a culture of continuous improvement (CI) and data-driven decision-making within the organization, ensuring compliance with ISO 13485 and other relevant regulations.

The successful and highly motivated candidate will work to identify the mechanism(s) of action of small molecular agents in cellular systems, evaluate the activity of small molecules in cell-based assays for oncology drug discovery, and help to enable new technologies for drug discovery efforts in cell models. Comfortable in a dynamic and energetic team-based environment, the ideal candidate will actively contribute to develop cell-based functional assays and problem resolving, reliably execute experiments, interpret and analyze results. Good lab practicing and multitasking are required. This job will require the candidate to have good organization, communication and teamwork skills as well as flexibility and versatility to meet deadlines.

Execute laboratory experiments. Assist in determining operational space for various process parameters to ensure efficient and successful scale up. Help evaluate safety of processes utilizing calorimetry data and stability data to fully understand the hazards and the trigger points of these hazards. Follow guidance from senior scientists or project leader to problem solve complex synthetic problems during development. Assist in scale up of processes in the kilo labs. Support scale up of processes in the pilot plant in a GMP environment. Collaborate with analytical chemists to complete work assignments. Contribute to laboratory organization (daily weigh checks, update of lab supplies inventory, lab supply purchase, lab cleaning, equipment calibration). Accurately collect reliable data in the form of lab procedure or reports to be used for updates to customers or during drafting of production’s MBR.

A Scientist I in Quality Control is responsible for an intermediate level of expertise in analytical chemistry, chromatographic methods of analysis and instrumentation, including troubleshooting. Directs and provides guidance to associate scientists.

We are seeking a detail-oriented and highly collaborative Scientist to join our Genomics team. This is an excellent opportunity for an early-career scientist to gain hands-on experience in a fast-paced environment supporting a wide range of client-driven studies. The successful candidate will have a solid foundation in molecular biology techniques such as PCR and nucleic acid handling, and excels in documentation, communication, and collaborative work.

We are seeking a motivated, detail-oriented individuals to join our GLP-compliant Genetic Toxicology Laboratory in Concord, OH. This full-time, on-site Associate Scientist-I role involves supporting in vitro and in vivo genetic toxicology assays, including bacterial reverse mutation assay (Ames Assay), in vitro Micronucleus Assay using using human lymphoblastoid (TK6) cell line and human peripheral blood lymphocyte (HPBL), and rodents in vivo Micronucleus assay, Comet Assay, and Pig-a assay. The successful candidate will be properly trained to perform hands-on laboratory procedures following study protocols, SOPs, and regulatory standards, contributing directly to data quality and compliance.

The Pilot Plant Lab Engineer supports process development and the production of low-volume products. Key responsibilities include performing SAP transactions, contributing to CIP projects, conducting Engineering Reviews, and managing equipment. Additionally, the role involves collaborating within the team and across departments to achieve project goals effectively.